Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods

ABSTRACT

Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having an upstream portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a mechanically isolated valve support coupled to the anchoring member and configured to support a prosthetic valve. The device can further include an atrial extension member extending radially outward from the upstream portion of the anchoring member and which is deformable without substantially deforming the anchoring member. In some embodiments, the upstream portion of the anchoring member and the extension member may be deformed while the valve support remains sufficiently stable.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/776,575, filed Sep. 14, 2015, now allowed, which is a 35U.S.C. 371 of International Application No. PCT/US2014/029549, filedMar. 14, 2014, which claims priority to U.S. Provisional PatentApplication No. 61/898,345, filed Oct. 31, 2013, and which is acontinuation-in-part of U.S. patent application Ser. No. 13/946,552,filed Jul. 19, 2013, now U.S. Pat. No. 9,034,032, which is acontinuation-in part of U.S. patent application Ser. No. 13/842,785,filed Mar. 15, 2013, now U.S. Pat. No. 9,039,757, which is acontinuation-in-part of International Application No. PCT/US2012/61219,filed on Oct. 19, 2012, which claims priority to U.S. Provisional PatentApplication No. 61/605,699, filed Mar. 1, 2012, and to U.S. ProvisionalPatent Application No. 61/549,044, filed Oct. 19, 2011, the disclosuresof which are incorporated herein in their entireties by reference. Thepresent application incorporates the subject matter of (1) InternationalPatent Application No. PCT/US2012/043636, filed Jun. 21, 2012; (2) U.S.Provisional Patent Application No. 61/549,037, filed Oct. 19, 2011; and(3) International Patent Application No. PCT/US2012/61215, filed Oct.19, 2012, in their entireties by reference.

TECHNICAL FIELD

The present technology relates generally to prosthetic heart valvedevices. In particular, several embodiments are directed to prostheticmitral valves and devices for percutaneous repair and/or replacement ofnative mitral valves and associated systems and methods.

BACKGROUND

Conditions affecting the proper functioning of the mitral valve include,for example, mitral valve regurgitation, mitral valve prolapse andmitral valve stenosis. Mitral valve regurgitation is a disorder of theheart in which the leaflets of the mitral valve fail to coapt intoapposition at peak contraction pressures, resulting in abnormal leakingof blood from the left ventricle into the left atrium. There are anumber of structural factors that may affect the proper closure of themitral valve leaflets. For example, many patients suffering from heartdisease experience dilation of the heart muscle, resulting in anenlarged mitral annulus. Enlargement of the mitral annulus makes itdifficult for the leaflets to coapt during systole. A stretch or tear inthe chordae tendineae, the tendons connecting the papillary muscles tothe inferior side of the mitral valve leaflets, may also affect properclosure of the mitral annulus. A ruptured chordae tendineae, forexample, may cause a valve leaflet to prolapse into the left atrium dueto inadequate tension on the leaflet. Abnormal backflow can also occurwhen the functioning of the papillary muscles is compromised, forexample, due to ischemia. As the left ventricle contracts duringsystole, the affected papillary muscles do not contract sufficiently toeffect proper closure.

Mitral valve prolapse, or when the mitral leaflets bulge abnormally upin to the left atrium, causes irregular behavior of the mitral valve andmay also lead to mitral valve regurgitation. Normal functioning of themitral valve may also be affected by mitral valve stenosis, or anarrowing of the mitral valve orifice, which causes impedance of fillingof the left ventricle in diastole.

Typically, treatment for mitral valve regurgitation has involved theapplication of diuretics and/or vasodilators to reduce the amount ofblood flowing back into the left atrium. Other procedures have involvedsurgical approaches (open and intravascular) for either the repair orreplacement of the valve. For example, typical repair approaches haveinvolved cinching or resecting portions of the dilated annulus.

Cinching of the annulus has been accomplished by the implantation ofannular or pen-annular rings which are generally secured to the annulusor surrounding tissue. Other repair procedures have also involvedsuturing or clipping of the valve leaflets into partial apposition withone another.

Alternatively, more invasive procedures have involved the replacement ofthe entire valve itself where mechanical valves or biological tissue areimplanted into the heart in place of the mitral valve. These invasiveprocedures are conventionally done through large open thoracotomies andare thus very painful, have significant morbidity, and require longrecovery periods.

However, with many repair and replacement procedures, the durability ofthe devices or improper sizing of annuloplasty rings or replacementvalves may result in additional problems for the patient. Moreover, manyof the repair procedures are highly dependent upon the skill of thecardiac surgeon where poorly or inaccurately placed sutures may affectthe success of procedures.

Less invasive approaches to aortic valve replacement have been developedin recent years. Examples of pre-assembled, percutaneous prostheticvalves include, e.g., the CoreValve Revalving® System fromMedtronic/Corevalve Inc. (Irvine, Calif., USA) and the Edwards-Sapien®Valve from Edwards Lifesciences (Irvine, Calif., USA). Both valvesystems include an expandable frame housing a tri-leaflet bioprostheticvalve. The frame is expanded to fit the substantially symmetric,circular and rigid aortic annulus. This gives the expandable frame inthe delivery configuration a symmetric, circular shape at the aorticvalve annulus, suitable to supporting a tri-leaflet prosthetic valve(which requires such symmetry for proper coaptation of the prostheticleaflets). Thus, aortic valve anatomy lends itself to an expandableframe housing a replacement valve since the aortic valve anatomy issubstantially uniform, symmetric, and fairly rigid.

Mitral valve replacement, compared with aortic valve replacement, posesunique anatomical obstacles, rendering percutaneous mitral valvereplacement significantly more challenging than aortic valvereplacement. First, unlike the relatively symmetric and uniform aorticvalve, the mitral valve annulus has a non-circular D-shape orkidney-like shape, with a non-planar, saddle-like geometry often lackingsymmetry. Such unpredictability makes it difficult to design a mitralvalve prosthesis having the ability to conform to the mitral annulus.Lack of a snug fit between the prosthesis and the native leaflets and/orannulus may leave gaps therein, creating backflow of blood through thesegaps. Placement of a cylindrical valve prosthesis, for example, mayleave gaps in commissural regions of the native valve, potentiallyresulting in perivalvular leaks in those regions.

Current prosthetic valves developed for percutaneous aortic valvereplacement are unsuitable for adaptation to the mitral valve. First,many of these devices require a direct, structural connection betweenthe device structure which contacts the annulus and/or leaflets and thedevice structure which supports the prosthetic valve. In severaldevices, the same stent posts which support the prosthetic valve alsocontact the annulus or other surrounding tissue, directly transferringto the device many of the distorting forces exerted by the tissue andblood as the heart contracts during each cardiac cycle. Most cardiacreplacement devices further utilize a tri-leaflet valve, which requiresa substantially symmetric, cylindrical support around the prostheticvalve for proper opening and closing of the three leaflets over years oflife. If these devices are subject to movement and forces from theannulus and other surrounding tissues, the prostheses may be compressedand/or distorted causing the prosthetic leaflets to malfunction.Moreover, the typical diseased mitral annulus is much larger than anyavailable prosthetic valve. As the size of the valve increases, theforces on the valve leaflets increase dramatically, so simply increasingthe size of an aortic prosthesis to the size of a dilated mitral valveannulus would require dramatically thicker, taller leaflets, and mightnot be feasible.

In addition to its irregular, unpredictable shape, which changes sizeover the course of each heartbeat, the mitral valve annulus lacks asignificant amount of radial support from surrounding tissue. The aorticvalve, for example, is completely surrounded by fibro-elastic tissue,helping to anchor a prosthetic valve by providing native structuralsupport. The mitral valve, on the other hand, is bound by musculartissue on the outer wall only. The inner wall of the mitral valve isbound by a thin vessel wall separating the mitral valve annulus from theinferior portion of the aortic outflow tract. As a result, significantradial forces on the mitral annulus, such as those imparted by anexpanding stent prostheses, could lead to collapse of the inferiorportion of the aortic tract with potentially fatal consequences.

The chordae tendineae of the left ventricle may also present an obstaclein deploying a mitral valve prosthesis. This is unique to the mitralvalve since aortic valve anatomy does not include chordae. The maze ofchordae in the left ventricle makes navigating and positioning adeployment catheter that much more difficult in mitral valve replacementand repair. Deployment and positioning of a prosthetic valve oranchoring device on the ventricular side of the native mitral valve isfurther complicated by the presence of the chordae.

The triscuspid valve on the right side of the heart, although itnormally has three leaflets, poses similar challenges to less invasivetreatment as the mitral valve. Therefore there is a need for a betterprosthesis to treat tricuspid valve disease as well.

Given the difficulties associated with current procedures, there remainsthe need for simple, effective, and less invasive devices and methodsfor treating dysfunctional heart valves.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent.

FIGS. 1 and 2 are schematic illustrations of a mammalian heart havingnative valve structures suitable for replacement with various prostheticheart valve devices in accordance with embodiments of the presenttechnology.

FIG. 3 is a schematic cross-sectional side view of a native mitral valveshowing the annulus and leaflets.

FIG. 4A is a schematic illustration of the left ventricle of a hearthaving either i) prolapsed leaflets in the mitral valve, or ii) mitralvalve regurgitation in the left ventricle of a heart having impairedpapillary muscles, and which are suitable for combination with variousprosthetic heart valve devices in accordance with embodiments of thepresent technology.

FIG. 4B is a schematic illustration of a heart in a patient sufferingfrom cardiomyopathy, and which is suitable for combination with variousprosthetic heart valve devices in accordance with embodiments of thepresent technology.

FIG. 5A is a schematic illustration of a native mitral valve of a heartshowing normal closure of native mitral valve leaflets.

FIG. 5B is a schematic illustration of a native mitral valve of a heartshowing abnormal closure of native mitral valve leaflets in a dilatedheart, and which is suitable for combination with various prostheticheart valve devices in accordance with embodiments of the presenttechnology.

FIG. 5C is a schematic illustration of a mitral valve of a heart showingdimensions of the annulus, and which is suitable for combination withvarious prosthetic heart valve devices in accordance with embodiments ofthe present technology.

FIG. 6A is a schematic, cross-sectional illustration of the heartshowing an antegrade approach to the native mitral valve from the venousvasculature, in accordance with various embodiments of the presenttechnology.

FIG. 6B is a schematic, cross-sectional illustration of the heartshowing access through the inter-atrial septum (IAS) maintained by theplacement of a guide catheter over a guidewire, in accordance withvarious embodiments of the present technology.

FIGS. 7 and 8 are schematic, cross-sectional illustrations of the heartshowing retrograde approaches to the native mitral valve through theaortic valve and arterial vasculature, in accordance with variousembodiments of the present technology.

FIG. 9 is a schematic, cross-sectional illustration of the heart showingan approach to the native mitral valve using a trans-apical puncture inaccordance with various embodiments of the present technology.

FIG. 10A shows an isometric view of a prosthetic heart valve device inaccordance with an embodiment of the present technology.

FIG. 10B illustrates a cut-away view of a heart showing the prosthetictreatment device of FIG. 10A implanted at a native mitral valve inaccordance with an embodiment of the present technology.

FIGS. 10C-10F are side, perspective cut-away, top, and bottom views,respectively, of a prosthetic heart valve device in accordance with anembodiment of the present technology.

FIG. 11A is a side view of a valve support in an expanded configurationin accordance with an embodiment of the present technology.

FIGS. 11B-11D are isometric views of additional embodiments of valvesupports with prosthetic valves mounted therein in accordance with thepresent technology.

FIGS. 11E-11G are side views of a valve support having support bands andprosthetic valves mounted therein in accordance with the presenttechnology.

FIG. 11H shows an isometric view of a prosthetic heart valve device inaccordance with another embodiment of the present technology.

FIGS. 12A-12C are side views of various longitudinal ribs flexing inresponse to a distorting force in accordance with further embodiments ofthe present technology.

FIG. 13A is a schematic, cross-sectional view of a prosthetic heartvalve device in accordance with another embodiment of the presenttechnology.

FIGS. 13B-13F are partial side views of prosthetic heart valve devicesillustrating a variety of longitudinal rib configurations in accordancewith additional embodiments of the present technology.

FIG. 14A is a schematic top view of a native mitral valve illustratingthe major and minor axes.

FIGS. 14B-14C are schematic top views of an anchoring member in anexpanded configuration and in a deployed configuration, respectively, inaccordance with an embodiment of the present technology.

FIG. 15 is an isometric view of a prosthetic heart valve deviceillustrated in a deployed configuration in accordance with an additionalembodiment of the present technology.

FIG. 16A is a top view of a prosthetic heart valve device illustrated inan expanded configuration in accordance with a further embodiment of thepresent technology.

FIGS. 16B-16C are a first side view and a second side view,respectively, of the prosthetic heart valve device of FIG. 16A.

FIG. 16D is a side view of a prosthetic heart valve device showing thelongitudinal axis of the anchoring member off-set from the longitudinalaxis of the valve support by a tilt angle in accordance with anotherembodiment of the present technology.

FIG. 16E is a schematic top view of a native mitral valve in the heartviewed from the left atrium and showing the prosthetic treatment deviceof FIG. 16A-16C implanted at the native mitral valve in accordance withan embodiment of the present technology.

FIGS. 17A-17C are schematic top and first and second side views of theprosthetic heart valve device of FIG. 16A showing dimensions and taperangles of various aspects of the device in accordance with embodimentsof the present technology.

FIG. 18 is an isometric view of an anchoring member illustrated in anexpanded configuration in accordance with yet another embodiment of thepresent technology.

FIGS. 19A-19C are isometric, side and top views, respectively, of aprosthetic heart valve device having a sealing member in accordance witha further embodiment of the present technology.

FIG. 20A is an isometric view of a prosthetic heart valve device withouta sealing member in accordance with an embodiment of the presenttechnology.

FIGS. 20B-20E are isometric views of prosthetic heart valve deviceshaving sealing members in accordance with additional embodiments of thepresent technology.

FIGS. 21A-21B are cross-sectional side and isometric views of aprosthetic heart valve device having a tubular valve support member inaccordance with a further embodiment of the present technology.

FIGS. 21C-21F are partial cross-sectional side views and an isometricview of prosthetic heart valve devices having a tubular valve supportmember in accordance with other embodiments of the present technology.

FIGS. 22A-22G and 221-22K are enlarged side views of various mechanismsof coupling a valve support to an anchoring member in accordance withadditional embodiments of the present technology.

FIG. 22H is a side view of a post in the prosthetic heart valve deviceof FIG. 40G.

FIGS. 23A-23B are enlarged side views of additional mechanisms forcoupling an anchoring member to a valve support member in accordancewith further embodiments of the present technology.

FIG. 24A is a perspective view of an integral connection between a valvesupport and an anchoring member in accordance with an additionalembodiment of the present technology.

FIGS. 24B-24D are enlarged views of additional embodiments of anintegral connection between a valve support and an anchoring member inaccordance with the present technology.

FIG. 25A is a partial cross-sectional view of a prosthetic heart valvedevice having an anchoring member and a valve support in accordance withan embodiment of the present technology.

FIG. 25B is an enlarged view of the designated box shown in FIG. 25A

FIGS. 26A-26D are schematic cross-sectional views of prosthetic heartvalve devices having atrial retainers and implanted at a native mitralvalve in accordance with various embodiments of the present technology.

FIG. 27 is a side view of an anchoring member having a vertical portionat the upstream end for engaging the annulus in accordance with anotherembodiment of the present technology.

FIG. 28 is a side view of a prosthetic heart valve device in an expandedconfiguration and having a plurality of stabilizing elements inaccordance with an embodiment of the present technology.

FIG. 29 is an enlarged schematic, side view of a prosthetic heart valvedevice having an extended arm in accordance with an embodiment of thepresent technology.

FIGS. 30A-30C are enlarged partial side views of a prosthetic heartvalve device having arms coupled to the device at various angles withrespect to a longitudinal axis of the device in accordance with furtherembodiments of the present technology.

FIGS. 31A-31C are enlarged, partial side views of a prosthetic heartvalve device having arms of various lengths coupled to the device inaccordance with additional embodiments of the present technology.

FIGS. 32A, 32B, 32C, and 32D are cross-sectional views of a heart withan implanted prosthetic heart valve device having arms disposed on aninward-facing surface of the leaflets in accordance with variousembodiments of the present technology.

FIGS. 32A-1, 32B-1, 32C-1 and 32D-1 are enlarged views of the armsengaging the inward-facing surface of the leaflets as shown in FIGS.32A, 32B, 32C and 32D, respectively in accordance with variousembodiments of the present technology.

FIGS. 33A-33C are schematic views illustrating various embodiments oftissue engaging elements for use with prosthetic heart valve devices inaccordance with the present technology.

FIGS. 34A, 34B and 34C are cross-sectional views of a heart with animplanted prosthetic heart valve device having arms with tissue engagingelements disposed on an inward-facing surface of the leaflets inaccordance with various embodiments of the present technology.

FIGS. 34A-1, 34B-1 and 34C-1 are enlarged views of the arms engaging theinward-facing surface of the leaflets as shown in FIGS. 34A, 34B and34C, respectively in accordance with various embodiments of the presenttechnology.

FIGS. 35A-35C are side views of prosthetic heart valve devices and shownimplanted at a mitral valve (illustrated in cross-section), the deviceshaving arms for engaging an outward-facing surface of the nativeleaflets in accordance with further embodiments of the presenttechnology.

FIG. 35C-1 is an enlarged view of the arm engaging the inward-facingsurface of the leaflets as shown in FIG. 35C in accordance with variousembodiments of the present technology.

FIG. 36A is a side view of a prosthetic heart valve device and shownimplanted at a mitral valve (illustrated in cross-section), the devicehaving arms for engaging an outward-facing surface of the nativeleaflets and arms for engaging an inward-facing surface of the nativeleaflets in accordance with an additional embodiment of the presenttechnology.

FIG. 36B is an enlarged view of the arms engaging the inward-facing andoutward-facing surfaces of the leaflets as shown in FIG. 36A.

FIGS. 37A-37D are enlarged side views of additional embodiments of armssuitable for use with a prosthetic heart valve device in accordance withthe present technology.

FIG. 38A is a side view of a prosthetic heart valve device having aplurality of non-interconnected arms in accordance with a furtherembodiment of the present technology.

FIG. 38B is a side view of a prosthetic heart valve device having aplurality of circumferentially connected arms in accordance with afurther embodiment of the present technology.

FIGS. 39A-39D are schematic top views of arm location patterns inaccordance with additional embodiments of the present technology.

FIGS. 40A-40D are side views of prosthetic heart valve devices havingtissue engaging elements on varying structures of the device inaccordance with additional embodiments of the present technology.

FIGS. 40E-40G are enlarged side views of tissue engaging elementssuitable for use with prosthetic heart valve devices in accordance withother embodiments of the present technology.

FIGS. 40I-40T are enlarged side views of embodiments of tissue engagingelements suitable for use with prosthetic heart valve devices inaccordance with additional embodiments of the present technology.

FIG. 41 is an isometric view of a prosthetic heart valve device having aplurality of annulus engaging elements in accordance with a furtherembodiment of the present technology.

FIGS. 42A-42B are cross-sectional side and enlarged views of aprosthetic heart valve device having tissue engaging elements deployablefrom a plurality of tubular ribs in accordance with another embodimentof the present technology.

FIGS. 43A-43B are an isometric view and an enlarged detail view of aprosthetic heart valve device having a sealing member configured withtissue engaging elements in accordance with another embodiment of thepresent technology

FIGS. 44A-44F are enlarged side views of embodiments of tissue engagingelements suitable for use with prosthetic heart valve devices inaccordance with additional embodiments of the present technology.

FIG. 45A is an isometric view of a prosthetic heart valve device havinga plurality of tethers between the anchoring member 110 and the valvesupport 120 in accordance with an embodiment of the present technology.

FIG. 45B is an isometric view of a prosthetic heart valve device havinga plurality of septa between the anchoring member 110 and the valvesupport 120 in accordance with another embodiment of the presenttechnology.

FIG. 46A is side partial cut-away view of a delivery system inaccordance with an embodiment of the present technology.

FIG. 46B is an enlarged cross-sectional view of a distal end of adelivery system in accordance with an embodiment of the presenttechnology.

FIGS. 46C-46D are enlarged partial side views of a valve supportconfigured for use with the delivery system of FIG. 46B in accordancewith an embodiment of the present technology.

FIGS. 47A-47D are cross-sectional views of a heart showing an antegradeor trans-septal approach to the mitral valve in accordance with anembodiment of the present technology.

FIGS. 48A-48C are cross-sectional views of the heart illustrating amethod of implanting a prosthetic heart valve device using atrans-septal approach in accordance with another embodiment of thepresent technology.

FIGS. 49A-49B are cross-sectional views of the heart showing aretrograde approach to the mitral valve via the aorta and left ventriclein accordance with a further embodiment of the present technology.

FIGS. 50A-50B are cross-sectional views of the heart illustrating afurther embodiment of a method of implanting the prosthetic heart valvedevice using a trans-apical approach in accordance with aspects of thepresent technology.

FIGS. 51A-51B are partial side views of a delivery system wherein aprosthetic heart valve device is mounted on an expandable balloon of adelivery catheter in accordance with another embodiment of the presenttechnology.

FIGS. 52A-52D are cross-sectional views of a heart showing a method ofdelivering a prosthetic heart valve device having a valve supportmovably coupled to an anchoring member in accordance with a furtherembodiment of the present technology.

FIGS. 53A-53D are partial side views showing various mechanisms formovably coupling the valve support to the anchoring member in accordancewith additional embodiments of the present technology.

FIG. 53E is a partial top view of the device of FIG. 53D.

FIG. 53F is a side view of an alternative mechanism for slideablycoupling a valve support and anchoring member in accordance with anotherembodiment of the present technology.

FIGS. 53G-53H are schematic side views of a prosthetic heart valvedevice showing yet another mechanism for coupling the valve support tothe anchoring member in accordance with a further embodiment of thepresent technology.

FIG. 54A is a cross-sectional side view of another embodiment of adelivery system for the prosthetic heart valve device in accordance withother aspects of the present technology.

FIG. 54B is a partial cross-sectional side view of a distal portion ofthe delivery system of FIG. 54A.

FIGS. 55A-55C are perspective views of the delivery system of FIG. 46illustrating the steps of delivering the prosthetic treatment device ofthe invention.

FIG. 56 is a side cross-sectional view of a further embodiment of adelivery system for the prosthetic treatment device of the invention.

FIGS. 57A-57D are isometric views of prosthetic treatment devices inaccordance with additional embodiments of the present technology.

FIG. 57E is a schematic cross-sectional view of the prosthetic heartvalve device of FIG. 57A implanted at a native mitral valve inaccordance with an embodiment of the present technology.

FIGS. 58A-58D are cross-sectional views of a heart showing a method ofdelivering a prosthetic heart valve device to a native mitral valve inthe heart using a trans-apical approach in accordance with anotherembodiment of the present technology.

FIGS. 59A-59C are isometric views of prosthetic treatment devices inaccordance with additional embodiments of the present technology.

FIG. 59D is a schematic cross-sectional view of a prosthetic heart valvedevice implanted at a native mitral valve in accordance with anotherembodiment of the present technology.

FIGS. 60A-60B are cross-sectional side views of a distal end of adelivery catheter for delivering the prosthetic heart valve device ofFIG. 59C to a native mitral valve in the heart in accordance withanother embodiment of the present technology.

FIG. 61 is a side view of a prosthetic heart valve device having firstand second anchoring members for engaging supra-annular and subannulartissue of the mitral valve, respectively, in accordance with yet anotherembodiment of the present technology.

FIGS. 62A-62C are partial cross-sectional side views of a distal end ofa delivery system showing delivery of the prosthetic heart valve deviceof FIG. 61 at a mitral valve in accordance with another embodiment ofthe present technology.

FIG. 63 is an isometric side view of a prosthetic heart valve devicehaving an anchoring member with a supra-annular engaging rim and asubannular engaging ring in accordance with a further embodiment of thepresent technology.

FIGS. 64A-64D are side views of the prosthetic heart valve device ofFIG. 63 showing embodiments of methods for deploying the device at themitral valve annulus in accordance with aspects of the presenttechnology.

FIG. 65A is a cross-sectional view of a prosthetic heart valve devicehaving an inflatable anchoring member and shown implanted in a nativemitral valve of a heart in accordance with another embodiment of thepresent disclosure.

FIG. 65B is a partial cross-sectional side view of a distal end of adelivery system suitable for delivery of the prosthetic heart valvedevice of FIG. 65A in accordance with another embodiment of the presenttechnology.

FIGS. 66A-66D are cross-sectional views of prosthetic heart valvedevices having Tillable chambers in accordance with additionalembodiments of the present technology.

FIGS. 67A-67B are isometric views of additional embodiments ofprosthetic heart valve devices in accordance with aspects of the presenttechnology.

FIGS. 68A-68B are side views of prosthetic heart valve devices having apositioning element in accordance with an additional embodiments of thepresent technology.

FIGS. 69A-69E are cross-sectional and side views of prosthetic heartvalve devices shown in an expanded configuration and configured inaccordance with an additional embodiment of the present technology.

FIG. 70 is a cross-sectional side view of another prosthetic heart valvedevice configured in accordance with an embodiment of the presenttechnology.

FIG. 71 is a cross-sectional side view of yet another prosthetic heartvalve device configured in accordance with an embodiment of the presenttechnology.

FIG. 72 is an isometric view of a prosthetic heart valve device inaccordance with another embodiment of the technology.

FIG. 73 is a side view of the prosthetic heart valve device of FIG. 72.

FIG. 74 is a bottom view of the prosthetic heart valve device of FIG.72.

FIG. 75 is a side view of a prosthetic heart valve device in accordancewith another embodiment of the technology.

FIG. 76 is a bottom view of the prosthetic heart valve device of FIG.75.

FIG. 77 is a side view of a prosthetic heart valve device in accordancewith another embodiment of the technology.

FIG. 78 is an isometric view of a prosthetic heart valve device inaccordance with another embodiment of the technology.

FIGS. 79A and 79B are partial anatomical cross-sections of a heart (H)and side views of an embodiment of a prosthetic heart valve device beingimplanted in accordance with a method of the present technology.

FIG. 79C is a partial anatomical cross-section of a heart (H) showingthe placement of the prosthetic heart valve device in accordance with anembodiment of the technology.

FIG. 79D is a partial anatomical cross-section of a heart (H) showingthe placement of the prosthetic heart valve device in accordance with anembodiment of the technology

FIGS. 80A-80Q are schematic cross-sectional views of several embodimentsof prosthetic heart valve devices in accordance with the presenttechnology.

FIG. 81A is a cross-sectional view of a prosthetic heart valve device inaccordance with another embodiment of the present technology.

FIG. 81B is a top view of the prosthetic heart valve device of FIG. 81A.

FIG. 82A is an isometric view of a prosthetic heart valve device inaccordance with another embodiment of the present technology.

FIG. 82B is a cross-sectional view of the prosthetic heart valve deviceof FIG. 82A taken along line 20B-20B.

FIG. 83 is a schematic cross-sectional view of a prosthetic heart valvedevice in accordance with another embodiment of the present technology.

FIGS. 84A-84C are schematic cross-section views of the operation ofprosthetic heart valve devices in accordance with the presenttechnology.

FIGS. 85A-85C are schematic side views of a portion of prosthetic heartvalve devices in accordance with the present technology.

FIGS. 86A-86B are side and isometric views of a prosthetic heart valvedevice in accordance with another embodiment of the technology.

FIGS. 87A-87B are side and top views of another prosthetic heart valvedevice in accordance with another embodiment of the technology.

FIGS. 88A-88C are cross-sectional views of a heart showing a method ofdelivering a prosthetic heart valve device to a native mitral valve inthe heart using a trans-apical approach in accordance with anotherembodiment of the present technology.

FIGS. 89A and 89B are schematic top views of a native mitral valve inthe heart viewed from the left atrium and showing the prosthetictreatment device of FIGS. 86A and 86B implanted at the native mitralvalve in accordance with the present technology.

FIGS. 90A-90F are schematic illustrations showing how the prostheticheart valve device of FIGS. 86A and 86B mechanically isolates the valvesupport in accordance with additional embodiments of the presenttechnology.

FIG. 91A is an isometric illustration of a prosthetic heart valve devicein accordance with yet another embodiment of the technology.

FIG. 91B is a cross-sectional view of the device shown in FIG. 91A.

FIG. 92 is a top view of a prosthetic heart valve device in accordancewith a further embodiment of the technology.

FIG. 93 is a top view of a prosthetic heart valve device in accordancewith another embodiment of the technology.

FIG. 94 is a top view of a prosthetic heart valve device in accordancewith yet another embodiment of the technology.

FIGS. 95A and 95B are top views of prosthetic heart valve devices inaccordance with further embodiments of the technology.

FIG. 96A is an isometric view a prosthetic heart valve device inaccordance with yet another embodiment of the technology.

FIGS. 96B and 96C are enlarged schematic views of portions of theprosthetic heart valve device of FIG. 96A.

FIGS. 97A and 97B are top and isometric views of a prosthetic heartvalve device in accordance with an embodiment of the technology.

FIGS. 98A-98C are top views of prosthetic heart valve devices inaccordance with further embodiments of the technology.

FIG. 99 is a top view of a prosthetic heart valve device in accordancewith yet another embodiment of the technology.

FIG. 100A is a side view showing a method of delivering a prostheticheart valve device in accordance with a further embodiment of thetechnology.

FIG. 100B is a top view of the prosthetic heart valve device of FIG.100A.

FIG. 101 is a top view of a prosthetic heart valve device in accordancewith another embodiment of the technology.

FIG. 102 is an isometric view of a prosthetic heart valve device inaccordance with an embodiment of the technology.

FIG. 103 isometric view of a prosthetic heart valve device in accordancewith a further embodiment of the technology.

FIGS. 104A and 104B are side views of prosthetic heart valve devices inaccordance with further embodiments of the technology.

FIG. 105 is an isometric view of a prosthetic heart valve device inaccordance with a yet another embodiment of the technology.

FIGS. 106A and 106B are schematic cross-sectional views of embodimentsof prosthetic heart valve devices in accordance with the presenttechnology.

FIGS. 107A and 107B are isometric views showing a method of delivering aprosthetic heart valve device in accordance with a further embodiment ofthe technology.

DETAILED DESCRIPTION

Specific details of several embodiments of the technology are describedbelow with reference to FIGS. 1-107B. Although many of the embodimentsare described below with respect to devices, systems, and methods forpercutaneous replacement of a native mitral valve using prosthetic valvedevices, other applications and other embodiments in addition to thosedescribed herein are within the scope of the technology. Additionally,several other embodiments of the technology can have differentconfigurations, components, or procedures than those described herein. Aperson of ordinary skill in the art, therefore, will accordinglyunderstand that the technology can have other embodiments withadditional elements, or the technology can have other embodimentswithout several of the features shown and described below with referenceto FIGS. 1-107B.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can reference arelative position of the portions of a prosthetic valve device and/or anassociated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various prostheticvalve devices described herein, “proximal” can refer to a positioncloser to the operator of the device or an incision into thevasculature, and “distal” can refer to a position that is more distantfrom the operator of the device or further from the incision along thevasculature (e.g., the end of the catheter). With respect to aprosthetic heart valve device, the terms “proximal” and “distal” canrefer to the location of portions of the device with respect to thedirection of blood flow. For example, proximal can refer to an upstreamposition or a position of blood inflow, and distal can refer to adownstream position or a position of blood outflow. For ease ofreference, throughout this disclosure identical reference numbers and/orletters are used to identify similar or analogous components orfeatures, but the use of the same reference number does not imply thatthe parts should be construed to be identical. Indeed, in many examplesdescribed herein, the identically numbered parts are distinct instructure and/or function. The headings provided herein are forconvenience only.

Overview

Systems, devices and methods are provided herein for percutaneousreplacement of native heart valves, such as mitral valves. Several ofthe details set forth below are provided to describe the followingexamples and methods in a manner sufficient to enable a person skilledin the relevant art to practice, make and use them. Several of thedetails and advantages described below, however, may not be necessary topractice certain examples and methods of the technology. Additionally,the technology may include other examples and methods that are withinthe scope of the claims but are not described in detail.

Embodiments of the present technology provide systems, methods andapparatus to treat valves of the body, such as heart valves includingthe mitral valve. The apparatus and methods enable a percutaneousapproach using a catheter delivered intravascularly through a vein orartery into the heart. Additionally, the apparatus and methods enableother less-invasive approaches including trans-apical, trans-atrial, anddirect aortic delivery of a prosthetic replacement valve to a targetlocation in the heart. The apparatus and methods enable a prostheticdevice to be anchored at a native valve location by engagement with asubannular surface of the valve annulus and/or valve leaflets.Additionally, the embodiments of the devices and methods as describedherein can be combined with many known surgeries and procedures, such asknown methods of accessing the valves of the heart (e.g., the mitralvalve or triscuspid valve) with antegrade or retrograde approaches, andcombinations thereof.

The devices and methods described herein provide a valve replacementdevice that has the flexibility to adapt and conform to thevariably-shaped native mitral valve anatomy while mechanically isolatingthe prosthetic valve from the anchoring portion of the device. Severalembodiments of the device effectively absorb the distorting forcesapplied by the native anatomy. The device has the structural strengthand integrity necessary to withstand the dynamic conditions of the heartover time, thus permanently anchoring a replacement valve and making itpossible for the patient to resume a substantially normal life. Thedevices and methods further deliver such a device in a less-invasivemanner, providing a patient with a new, permanent replacement valve butalso with a lower-risk procedure and a faster recovery.

In accordance with various embodiments of the present technology, adevice for repair or replacement of a native valve of a heart isdisclosed. The native valve has an annulus and leaflets, and the deviceincludes an anchoring member having a first portion configured to engagetissue on or under the annulus and to deform in a non-circular shape toconform to the tissue. The anchoring member also can include a secondportion. The device also includes a valve support coupled to the secondportion of the anchoring member and configured to support a prostheticvalve and having a cross-sectional shape. In various embodiments, thefirst portion of the anchoring member is mechanically isolated from thevalve support such that the cross-sectional shape of the valve supportremains sufficiently stable so that the prosthetic valve remainscompetent when the anchoring member is deformed in the non-circularshape.

Some embodiments of the disclosure are directed to prosthetic heartvalve devices for implantation at a native mitral valve wherein themitral valve has an annulus and leaflets. In one embodiment, the devicecan have an anchoring member positionable in a location between theleaflets, wherein a first portion of the anchoring member is expandableto a dimension larger than a corresponding dimension of the annulus. Inthis embodiment, upstream movement of the anchoring member is blocked byengagement of the upstream portion with tissue on or near the annulus.The anchoring member can also include a second portion. The device canalso include a valve support coupled to the second portion of theanchoring member, wherein an upstream region of the valve support isspaced radially inward from at least the first portion of the anchoringmember. The valve support can be configured to support a prostheticvalve.

In another arrangement, a device for implantation at a native valvehaving an annulus and leaflets can include a hyperboloidic anchoringmember having an upstream end configured to engage an inward facingsurface of the leaflets downstream of the annulus and a downstream end,wherein the upstream end has a larger cross-sectional area than thedownstream end. The device can also include a valve support positionedin the anchoring member and configured to support a prosthetic valve.The valve support is coupled to the anchoring member at a locationspaced substantially downstream from the upstream end and is uncoupledto the anchoring member at the upstream end.

Other aspects of the disclosure are directed to prosthetic heart valvedevices for repair or replacement of a native heart valve of a patient,wherein the heart valve has an annulus and leaflets. In one embodiment,the device includes an anchoring member having a first portion having afirst cross-sectional dimension and second portion having a secondcross-sectional dimension less than the first cross-sectional dimension.The first portion is configured to engage cardiac tissue to retain theanchoring member in a fixed longitudinal position relative to theannulus. The device can also include a valve support coupled to thesecond portion of the anchoring member and configured to support aprosthetic valve. The valve support can be radially separated from thefirst portion of the anchoring member such that the first portion candeform inwardly without substantially deforming the valve support.

In a further arrangement, the present disclosure also is directed to adevice for implantation at a native heart valve. The device can includean anchoring member having an upstream end configured to engage tissueon or downstream of a native annulus of the heart valve, and a valvesupport configured to support a prosthetic valve. The valve support canbe coupled to the anchoring member. In some arrangements, the anchoringmember can resist upstream migration of the device without an element ofthe device extending behind native valve leaflets.

In another embodiment, the device can include an anchoring memberpositionable between the leaflets of the native valve. The anchoringmember can have a plurality of tissue engaging elements on an upstreamend and/or on an exterior surface which are configured to engage cardiactissue on or near the annulus so as to prevent migration of the devicein the upstream direction. The device can also include a valve supportpositioned within an interior of the anchoring member and coupled to adownstream portion of the anchoring member, wherein the valve support isradially separated from at least an upstream portion of the anchoringmember.

Further embodiments of the disclosure are directed to a device forrepair or replacement of a native mitral valve having an annulus and apair of leaflets that include a support structure having an upperregion, a lower region, and an interior to retain a prosthetic valve.The device can also include an anchoring member surrounding at least aportion of the support structure, wherein the anchoring member ispositionable between the leaflets and has a plurality of flexibleelements (e.g., wires, laser cut metal elements, etc.) arranged in adiamond pattern, an upper portion, and a lower portion. The upperportion of the anchoring member can be flared outwardly in a proximaldirection such that proximal ends of the flexible elements pointradially outward so as to engage cardiac tissue on or near the annulusand inhibit migration of the device in the upstream direction. The lowerregion of the support structure can be coupled to the lower portion ofthe anchoring member, and the lower region of the support structure canbe mechanically isolated from at least deformation of the flared upperportion of the anchoring member.

Other embodiments of the disclosure are directed to prosthetic heartvalve devices having a cylindrical support and an anchor defined by astructure separate from the cylindrical support. The cylindrical supportcan have a longitudinal axis and an interior along the longitudinal axisthrough which blood may flow. The anchor can have a non-circularcross-section with an outwardly flared upstream end configured to engagesubannular tissue of a mitral valve. The anchor can also surround thecylindrical support and be coupled to the support at a downstream endopposite the upstream end.

In a further embodiment, the device can include an expandable valvesupport configured for placement between the two leaflets. The supportcan have a first region, a second region and an interior in which avalve may be coupled. The device can also include an anchoring memberhaving a first portion and a second portion, the second portion coupledto the second region of the valve support. The first portion of theanchoring member can extend outwardly away from the second portion. Theanchoring member can have a first perimeter at the first portionconfigured to engage tissue on or near the annulus. The anchoring membercan be mechanically isolated from the valve support such that a forceexerted radially at or near the first perimeter will not substantiallyalter a shape of the valve support.

Additional embodiments are directed to devices to treat a heart valve ofa patient that include an inner frame and an outer frame coupled to theinner frame. The inner frame can have an outer surface and an innersurface that is configured to support a prosthetic valve. The outerframe can have an upper portion with a cross-sectional dimension greaterthan a corresponding cross-sectional dimension of an annulus of themitral valve, wherein the upper portion is configured to engage tissueat or below the annulus of the mitral valve. The upper portion can alsoprevent migration of the device in an upward or upstream directionduring ventricular systole. Further, the upper portion of the outerframe can be mechanically isolated from the inner frame.

In a further embodiment, the device can include a cylindrical innerskeleton and an outer skeleton coupled to the inner skeleton andpositionable between the leaflets downstream of the annulus. The outerskeleton can be deformable to a non-circular cross-section while theinner skeleton remains substantially circular in cross-section. Theinner skeleton can have an interior to which a prosthetic valve may becoupled. The outer skeleton can have a plurality of flexible elements(e.g., wires, laser cut metal elements, etc.), wherein at least aportion of the flexible elements can be configured to engage nativesubannular tissue so as to prevent migration of the device in anupstream direction. In one embodiment, the plurality of flexible wiresare arranged in a diamond configuration.

In yet a further embodiment, a prosthetic mitral valve device caninclude a valve support having upstream and downstream ends, an interiorin which a valve may be coupled, and a perimeter. The device can alsoinclude an anchoring member having a flared upstream portion and adownstream portion coupled to the perimeter of the valve support. Theupstream portion can be mechanically isolated from the valve support andcan be configured to engage subannular tissue of a native mitral valve.Additionally, the device can be moveable into a plurality ofconfigurations including a first configuration in which the valvesupport and the anchoring member are radially contracted, and whereinthe valve support has a first cross-sectional shape. The device can alsomove into a second configuration in which the valve support and theanchoring member are radially expanded and in which the valve supporthas a second cross-sectional shape. Additionally, the device can moveinto a third configuration in which the anchoring member is engaged withand deformed by the subannular tissue while the valve support remains inthe second cross-sectional shape.

In some embodiments, the device may comprise an atrial retainerextending from the anchoring member or the valve support to a positionat least partially upstream of the native mitral annulus. The atrialextension member may comprise an atrial engagement structure adapted toengage an upstream surface (e.g., supra-annular surface) of the annulusand/or an interior wall of the atrium for further stabilizing oranchoring the device. For example, the atrial retainer can blockdownstream movement of the device.

Some embodiments of the device may further comprise one or morestabilizing members to inhibit the device from tilting or beingdisplaced laterally. The stabilizing members may comprise a plurality ofarms extending radially outwardly from the valve support and/or theanchoring member. The arms may be configured to extend behind the nativeleaflets and/or into engagement with the ventricular wall or papillarymuscles.

A further embodiment, in accordance with another aspect of the presentdisclosure, is directed to a device for implantation at a native mitralvalve, wherein the native mitral valve has an annulus and leaflets. Thedevice can include a valve support having upstream and downstream ends,an interior in which a valve may be coupled, and an outer surface, andinclude a first anchoring member having a first flared upstream portionand a first downstream portion coupled to the outer surface of the valvesupport. In other embodiments, the first downstream portion can becoupled to inner surface of the valve support, or in some embodiments,to an end of the valve support. The device can also include a secondanchoring member at least partially surrounding the first anchoringmember. The first upstream portion of the first anchoring member can bemechanically isolated from the valve support and configured to engagesupra-annular tissue of the native mitral valve. The second anchoringmember can have a second flared upstream portion and a second downstreamportion coupled to the outer surface of the valve support, wherein thesecond upstream portion can be mechanically isolated from the valvesupport and is configured to engage subannular tissue of the nativemitral valve.

In yet a further embodiment, the device for implantation can include aradially expandable anchoring member configured to engage native tissueon or downstream of the annulus. The anchoring member can have a firstlongitudinal length on a posterior leaflet-facing side and a secondlength on an anterior leaflet-facing side. In certain embodiments, thefirst length can be greater than the second length such that occlusionof a left ventricle outflow tract (LVOT) is limited. The device can alsoinclude a valve support, or alternatively a prosthetic valve, coupled toan interior or to an end of the anchoring member.

Other embodiments of the present technology provide a device forimplantation at a native mitral valve having an annulus and leaflets,wherein the device includes a valve support having upstream anddownstream ends, an interior in which a valve may be coupled, and anouter surface. The device can also include an anchoring member having aflared upstream portion and a downstream portion coupled to the outersurface of the valve support, wherein the upstream portion can have anupper ring and a lower ring coupled to the upper ring. The device canfurther include a plurality of flexible annulus engaging elementsdistributed around a circumference of the anchoring member and couplingthe upper ring to the lower ring. The lower ring is configured to movein an upstream direction toward the upper ring such that the annulus isreceived between the upper and lower rings and within the annulusengaging elements.

The disclosure further provides systems for delivery of prostheticvalves and other devices using endovascular or other minimally invasiveforms of access. For example, embodiments of the present technologyprovide a system to treat a mitral valve of a patient, in which themitral valve has an annulus. The system comprises a device to treat themitral valve as described herein and a catheter having a lumenconfigured to retain the device within the catheter.

In other aspects, a system for replacing a native valve in a patient isprovided. The system can include an elongated catheter body having adistal end and a proximal end, and a housing coupled to the distal endof the catheter body and having a closed end and an open end. The systemcan also include a plunger within the housing which is axially movablerelative to the housing, and an actuator at the proximal end of thecatheter body and coupled to the plunger such that moving the actuatormoves the housing axially relative to the plunger. The system canfurther include a prosthetic valve device having a collapsedconfiguration and an expanded configuration. The prosthetic valve devicecan be positionable in the housing in the collapsed configuration andcan be releasable proximally from the housing by moving the actuator.

In yet another aspect, embodiments of the present technology provide amethod of treating a heart valve of a patient. The mitral valve has anannulus and leaflets coupled to the annulus. The method can includeimplanting a device as described herein within or adjacent to theannulus. The device, in some embodiments, can include a valve supportcoupled to and at least partially surrounded by an anchoring member. Theanchoring member can be disposed between the leaflets and an upstreamportion of the anchoring member can be configured to engage tissue on ordownstream of the annulus to prevent migration of the device in anupstream direction. Further, the valve support can be mechanicallyisolated from the anchoring member at least at the upstream portion.

In yet a further aspect, embodiments of the present technology provide amethod for replacement of a native mitral valve having an annulus andleaflets. The method can include positioning a device as describedherein between the leaflets, while the device is in a collapsedconfiguration. The method can also include allowing the prostheticdevice to expand such that an anchoring member of the prosthetic deviceis in a subannular position in which it engages tissue on or downstreamof the annulus. The anchoring member can have a diameter larger than acorresponding diameter of the annulus in the subannular position. Themethod can further include allowing a valve support to expand within theanchoring member, wherein the valve support is coupled to the anchoringmember. In various embodiments, the valve support can be mechanicallyisolated from the anchoring member such that deformation of theanchoring member when the anchoring member engages the tissue does notsubstantially deform the valve support. In some arrangements, certainregions of the valve support may deform, but a support region suitablefor retaining a prosthetic valve does not substantially deform such thatleaflet coaptation of the prosthetic valve would not be compromised.

The disclosure further provides prosthetic heart valve devices that caninclude an anchoring member having a tubular fixation frame with aninlet end and an outlet end. The device can also include a tubular valvesupport that has a first portion coupled to the anchoring member and asecond portion mechanically isolated from the anchoring member such thatthe inlet end of the anchoring member is radially deformable withoutsubstantially deforming the second portion. The device can furtherinclude a valve coupled to the valve support. The valve can have atleast one leaflet movable from a closed position in which blood flow isblocked through the valve support and an open position in which bloodflow is allowed through the valve support in a downstream direction. Thedevice can also include an extension member coupled to the fixationframe and extending radially outward therefrom. A deformable portion ofthe extension member can be mechanically isolated from the anchoringmember such that the deformable portion of the extension member isradially deformable without substantially deforming the anchoringmember.

Additional aspects of the disclosure are directed to prosthetic heartvalve devices that can include an anchoring member that has a connectionstructure and a radially expandable fixation frame. The connectionstructure can have a first end coupled to the fixation frame, a secondend coupled to a valve support and a lateral portion that spaces thefixation frame apart from the valve support. The device can also includea valve coupled to the valve support and which has at least one leafletmovable from a closed position in which blood flow is blocked through aninterior and an open position in which blood flow is allowed through theinterior in a flow direction from an inlet end toward an outlet end. TheDevice can further include an extension member having a brim and asupport structure coupled to the brim. The brim can include a sheet offlexible material coupled to the fixation frame and extending radiallyoutward therefrom. In various embodiments, the support structure can bemore rigid than the brim. In one embodiment, the brim can be deflectablerelative to the fixation frame about an axis transverse to the flowdirection and the fixation frame is configured to deform at leastpartially independently of the valve support.

Additional prosthetic heart valve devices can include an anchoringmember having a tubular fixation frame with an interior and having anupstream end and a downstream end, and a valve coupled to the anchoringmember. The valve can have at least one leaflet movable from a closedposition in which blood flow is blocked through the interior and an openposition in which blood flow is allowed through the interior in a flowdirection from the upstream end toward the downstream end. The devicecan also include an extension member having a brim and a resilientsupport structure coupled to the brim. The brim can include a sheet offlexible material coupled to the anchoring member near the upstream endthereof and extending radially outward therefrom. The support structurecan be structurally independent from the fixation frame. Further, theextension member can be radially deformable without substantiallydeforming the anchoring member.

In yet a further aspect, a prosthetic heart valve device can include ananchoring member having a radially expandable frame with an interior andhaving an upstream end and a downstream end. In some embodiments, theupstream end includes a tissue fixation portion configured to engagetissue located at and/or downstream of a native annulus of a heart valvein a subject and configured to be at least partially deformable toconform to a shape of the tissue. The device can also include a valvepositioned relative to the anchoring member and having at least oneleaflet movable from a closed position in which blood flow is blockedthrough the interior and an open position in which blood flow is allowedthrough the interior in a flow direction from the upstream end towardthe downstream end. The valve can be spaced inwardly apart from thetissue fixation portion of the anchoring member such that the valveremains competent when the tissue fixation portion is deformed toconform to the shape of the tissue. The device can further include anextension member flexibly coupled to the anchoring member proximate theupstream end of the expandable frame, wherein the extension memberextends longitudinally along the flow direction in a low-profileconfiguration and is biased to project laterally relative to the flowdirection in a deployed configuration. The extension member can beconfigured to deform relative to the expandable frame in the deployedconfiguration.

Additional aspects of the technology are directed to methods ofreplacing a native heart valve. In one embodiment, a method can includepositioning a prosthesis in a first heart chamber upstream of a nativeannulus with a delivery device when the prosthesis being is a collapsedconfiguration, and deploying an extension member of the prosthesis inthe first heart chamber so that the extension member at least partiallyexpands into an expanded shape while an anchoring member of theprosthesis remains at least partially collapsed. The method can alsoinclude moving the prosthesis to cause an indicator portion of theextension member to deflect by engagement with a wall of the first heartchamber surrounding the native heart valve, and visualizing theindicator portion of the extension member to determine a position of theprosthesis relative to a native annulus based on the deflection of theindicator portion. The method can further include deploying theanchoring member of the prosthesis such that it expands into engagementwith heart tissue downstream of the native annulus so as to anchor theprosthesis in place.

Another method of replacing a native heart valve can include positioninga prosthesis in a first heart chamber upstream of a native annulus witha delivery device when the prosthesis is in a collapsed configuration,and deploying an extension member of the prosthesis in the first heartchamber so that the extension member at least partially expands into anexpanded shape while an anchoring member of the prosthesis remains atleast partially collapsed. The method can also include deploying theanchoring member of the prosthesis such that it expands into engagementwith heart tissue downstream of the native annulus so as to anchor theprosthesis in place. The method can further include allowing theextension member to radially deform to a greater extent than anydeformation of the anchoring member.

An additional method of replacing a native heart valve can includepositioning a collapsed prosthesis in a first heart chamber upstream ofa native annulus with a delivery device, and deploying an extensionmember of the prosthesis in the first heart chamber so that theextension member at least partially expands into an expanded shape whilea fixation member of the prosthesis remains at least partiallycollapsed. The method can also include moving the prosthesis in adownstream direction such that the expanded extension member folds atleast partially inwardly and positions the fixation member at a desiredlocation relative to the native valve annulus. The method can furtherinclude deploying the fixation member of the prosthesis such that itexpands into engagement with heart tissue downstream of the nativeannulus so as to anchor the prosthesis in place.

The devices and methods disclosed herein can be configured for treatingnon-circular, asymmetrically shaped valves and bileaflet or bicuspidvalves, such as the mitral valve. It can also be configured for treatingother valves of the heart such as the tricuspid valve. Many of thedevices and methods disclosed herein can further provide for long-term(e.g., permanent) and reliable anchoring of the prosthetic device evenin conditions where the heart or native valve may experience gradualenlargement or distortion.

Cardiac and Mitral Valve Physiology

FIGS. 1 and 2 show a normal heart H. The heart comprises a left atriumthat receives oxygenated blood from the lungs via the pulmonary veins PVand pumps this oxygenated blood through the mitral valve MV into theleft ventricle LV. The left ventricle LV of a normal heart H in systoleis illustrated in FIG. 2. The left ventricle LV is contracting and bloodflows outwardly through the aortic valve AV in the direction of thearrows. Back flow of blood or “regurgitation” through the mitral valveMV is prevented since the mitral valve is configured as a “check valve”which prevents back flow when pressure in the left ventricle is higherthan that in the left atrium LA.

The mitral valve MV comprises a pair of leaflets having free edges FEwhich meet evenly, or “coapt” to close, as illustrated in FIG. 2. Theopposite ends of the leaflets LF are attached to the surrounding heartstructure via an annular region of tissue referred to as the annulus AN.FIG. 3 is a schematic cross-sectional side view of an annulus andleaflets of a mitral valve. As illustrated, the opposite ends of theleaflets LF are attached to the surrounding heart structure via afibrous ring of dense connective tissue referred to as the annulus AN,which is distinct from both the leaflet tissue LF as well as theadjoining muscular tissue of the heart wall. The leaflets LF and annulusAN are comprised of different types of cardiac tissue having varyingstrength, toughness, fibrosity, and flexibility. Furthermore, the mitralvalve MV may also comprise a unique region of tissue interconnectingeach leaflet LF to the annulus AN, referred to herein as leaflet/annulusconnecting tissue LAC (indicated by overlapping cross-hatching). Ingeneral, annular tissue AN is tougher, more fibrous, and stronger thanleaflet tissue LF.

Referring to FIG. 2, the free edges FE of the mitral leaflets LF aresecured to the lower portions of the left ventricle LV through chordaetendineae CT (referred to hereinafter “chordae”) which include aplurality of branching tendons secured over the lower surfaces of eachof the valve leaflets LF. The chordae CT in turn, are attached to thepapillary muscles PM, which extend upwardly from the lower wall of theleft ventricle LV and interventricular septum IVS.

Referring now to FIGS. 4A to 4B, a number of structural defects in theheart can cause mitral valve regurgitation. Ruptured chordae RCT, asshown in FIG. 4A, can cause a valve leaflet LF2 to prolapse sinceinadequate tension is transmitted to the leaflet via the chordae. Whilethe other leaflet LF1 maintains a normal profile, the two valve leafletsdo not properly meet and leakage from the left ventricle LV into theleft atrium LA will occur, as shown by the arrow.

Regurgitation also occurs in the patients suffering from cardiomyopathywhere the heart is dilated and the increased size prevents the valveleaflets LF from meeting properly, as shown in FIG. 4B. The enlargementof the heart causes the mitral annulus to become enlarged, making itimpossible for the free edges FE to meet during systole. The free edgesof the anterior and posterior leaflets normally meet along a line ofcoaptation C as shown in FIG. 5A, but a significant gap G can be left inpatients suffering from cardiomyopathy, as shown in FIG. 5B.

Mitral valve regurgitation can also occur in patients who have sufferedischemic heart disease where the functioning of the papillary muscles PMis impaired, as illustrated in FIG. 4A. As the left ventricle LVcontracts during systole, the papillary muscles PM do not contractsufficiently to effect proper closure. One or both of the leaflets LF1and LF2 then prolapse. Leakage again occurs from the left ventricle LVto the left atrium LA.

FIGS. 5A-5C further illustrate the shape and relative sizes of theleaflets L of the mitral valve. Referring to FIG. 5C, it may be seenthat the overall valve has a generally “D”-shape or kidney-like shape,with a long axis MVA1 and a short axis MVA2. In healthy humans the longaxis MVA1 is typically within a range from about 33.3 mm to about 42.5mm in length (37.9+/−4.6 mm), and the short axis MVA2 is within a rangefrom about 26.9 to about 38.1 mm in length (32.5+/−5.6 mm). However,with patients having decreased cardiac function these values can belarger, for example MVA1 can be within a range from about 45 mm to 55 mmand MVA2 can be within a range from about 35 mm to about 40 mm. The lineof coaptation C is curved or C-shaped, thereby defining a relativelylarge anterior leaflet AL and substantially smaller posterior leaflet PL(FIG. 5A). Both leaflets appear generally crescent-shaped from thesuperior or atrial side, with the anterior leaflet AL beingsubstantially wider in the middle of the valve than the posteriorleaflet. As illustrated in FIG. 5A, at the opposing ends of the line ofcoaptation C the leaflets join together at corners called theanterolateral commissure AC and posteromedial commissure PC,respectively.

FIG. 5C shows the shape and dimensions of the annulus of the mitralvalve. The annulus is an annular area around the circumference of thevalve comprised of fibrous tissue which is thicker and tougher than thatof the leaflets LF and distinct from the muscular tissue of theventricular and atrial walls. The annulus may comprise a saddle-likeshape with a first peak portion PP1 and a second peak portion PP2located along an interpeak axis IPD, and a first valley portion VP1 anda second valley portion VP2 located along an intervalley axis IVD. Thefirst and second peak portion PP1 and PP2 are higher in elevationrelative to a plane containing the nadirs of the two valley portionsVP1, VP2, typically being about 8-19 mm higher in humans, thus givingthe valve an overall saddle-like shape. The distance between the firstand second peak portions PP1, PP2, referred to as interpeak span IPD, issubstantially shorter than the intervalley span IVD, the distancebetween first and second valley portions VP1, VP2.

A person of ordinary skill in the art will recognize that the dimensionsand physiology of the patient may vary among patients, and although somepatients may comprise differing physiology, the teachings as describedherein can be adapted for use by many patients having variousconditions, dimensions and shapes of the mitral valve. For example, workin relation to embodiments suggests that some patients may have a longdimension across the annulus and a short dimension across the annuluswithout well-defined peak and valley portions, and the methods anddevice as described herein can be configured accordingly.

Access to the Mitral Valve

Access to the mitral valve or other atrioventricular valve can beaccomplished through the patient's vasculature in a percutaneous manner.By percutaneous it is meant that a location of the vasculature remotefrom the heart is accessed through the skin, typically using a surgicalcut down procedure or a minimally invasive procedure, such as usingneedle access through, for example, the Seldinger technique. The abilityto percutaneously access the remote vasculature is well-known anddescribed in the patent and medical literature. Depending on the pointof vascular access, the approach to the mitral valve may be antegradeand may rely on entry into the left atrium by crossing the inter-atrialseptum. Alternatively, approach to the mitral valve can be retrogradewhere the left ventricle is entered through the aortic valve. Oncepercutaneous access is achieved, the interventional tools and supportingcatheter(s) may be advanced to the heart intravascularly and positionedadjacent the target cardiac valve in a variety of manners, as describedherein.

Using a trans-septal approach, access is obtained via the inferior venacava IVC or superior vena cava SVC, through the right atrium RA, acrossthe inter-atrial septum IAS and into the left atrium LA above the mitralvalve MV.

As shown in FIG. 6A, a catheter 1 having a needle 2 may be advanced fromthe inferior vena cava IVC into the right atrium RA. Once the catheter 1reaches the anterior side of the inter-atrial septum IAS, the needle 2may be advanced so that it penetrates through the septum, for example atthe fossa ovalis FO or the foramen ovale into the left atrium LA. Atthis point, a guidewire may be exchanged for the needle 2 and thecatheter 1 withdrawn.

As shown in FIG. 6B, access through the inter-atrial septum IAS mayusually be maintained by the placement of a guide catheter 4, typicallyover a guidewire 6 which has been placed as described above. The guidecatheter 4 affords subsequent access to permit introduction of thedevice to replace the mitral valve, as described in more detail herein.

In an alternative antegrade approach (not shown), surgical access may beobtained through an intercostal incision, preferably without removingribs, and a small puncture or incision may be made in the left atrialwall. A guide catheter may then be placed through this puncture orincision directly into the left atrium, sealed by a purse string-suture.

The antegrade or trans-septal approach to the mitral valve, as describedabove, can be advantageous in many respects. For example, the use of theantegrade approach will usually allow for more precise and effectivecentering and stabilization of the guide catheter and/or prostheticvalve device. Precise positioning facilitates accuracy in the placementof the prosthetic valve device. The antegrade approach may also reducethe risk of damaging the chordae tendinae or other subvalvularstructures during catheter and interventional tool introduction andmanipulation. Additionally, the antegrade approach may decrease risksassociated with crossing the aortic valve as in retrograde approaches.This can be particularly relevant to patients with prosthetic aorticvalves, which cannot be crossed at all or without substantial risk ofdamage.

An example of a retrograde approach to the mitral valve is illustratedin FIGS. 7 and 8. The mitral valve MV may be accessed by an approachfrom the aortic arch AA, across the aortic valve AV, and into the leftventricle LV below the mitral valve MV. The aortic arch AA may beaccessed through a conventional femoral artery access route, as well asthrough more direct approaches via the brachial artery, axillary artery,radial artery, or carotid artery. Such access may be achieved with theuse of a guidewire 6. Once in place, a guide catheter 4 may be trackedover the guidewire 6. Alternatively, a surgical approach may be takenthrough an incision in the chest, preferably intercostally withoutremoving ribs, and placing a guide catheter through a puncture in theaorta itself. The guide catheter 4 affords subsequent access to permitplacement of the prosthetic valve device, as described in more detailherein.

In some specific instances, a retrograde arterial approach to the mitralvalve may be selected due to certain advantages. For example, use of theretrograde approach can eliminate the need for a trans-septal puncture.The retrograde approach is also more commonly used by cardiologists andthus has the advantage of familiarity.

An additional approach to the mitral valve is via trans-apical puncture,as shown in FIG. 9. In this approach, access to the heart is gained viathoracic incision, which can be a conventional open thoracotomy orsternotomy, or a smaller intercostal or sub-xyphoid incision orpuncture. An access cannula is then placed through a puncture, sealed bya purse-string suture, in the wall of the left ventricle at or near theapex of the heart. The catheters and prosthetic devices of the inventionmay then be introduced into the left ventricle through this accesscannula.

The trans-apical approach has the feature of providing a shorter,straighter, and more direct path to the mitral or aortic valve. Further,because it does not involve intravascular access, the trans-apicalprocedure can be performed by surgeons who may not have the necessarytraining in interventional cardiology to perform the catheterizationsrequired in other percutaneous approaches.

The prosthetic treatment device may be specifically designed for theapproach or interchangeable among approaches. A person of ordinary skillin the art can identify an appropriate approach for an individualpatient and design the treatment apparatus for the identified approachin accordance with embodiments described herein.

Orientation and steering of the prosthetic valve device can be combinedwith many known catheters, tools and devices. Such orientation may beaccomplished by gross steering of the device to the desired location andthen refined steering of the device components to achieve a desiredresult.

Gross steering may be accomplished by a number of methods. A steerableguidewire may be used to introduce a guide catheter and the prosthetictreatment device into the proper position. The guide catheter may beintroduced, for example, using a surgical cut down or Seldinger accessto the femoral artery in the patient's groin. After placing a guidewire,the guide catheter may be introduced over the guidewire to the desiredposition. Alternatively, a shorter and differently shaped guide cathetercould be introduced through the other routes described above.

A guide catheter may be pre-shaped to provide a desired orientationrelative to the mitral valve. For access via the trans-septal approach,the guide catheter may have a curved, angled or other suitable shape atits tip to orient the distal end toward the mitral valve from thelocation of the septal puncture through which the guide catheterextends. For the retrograde approach, as shown in FIGS. 7 and 8, guidecatheter 4 may have a pre-shaped J-tip which is configured so that itturns toward the mitral valve MV after it is placed over the aortic archAA and through the aortic valve AV. As shown in FIG. 7, the guidecatheter 4 may be configured to extend down into the left ventricle LVand to assume a J-shaped configuration so that the orientation of aninterventional tool or catheter is more closely aligned with the axis ofthe mitral valve MV. In either case, a pre-shaped guide catheter may beconfigured to be straightened for endovascular delivery by means of astylet or stiff guidewire which is passed through a lumen of the guidecatheter. The guide catheter might also have pull-wires or other meansto adjust its shape for more fine steering adjustment.

Selected Embodiments of Prosthetic Heart Valve Devices and Methods

Embodiments of the present technology as described herein can be used totreat one or more of the valves of the heart as described herein, and inparticular embodiments, can be used for treatment of the mitral valve.Introductory examples of prosthetic heart valve devices, systemcomponents and associated methods in accordance with embodiments of thepresent technology are described in this section with reference to FIGS.10A-56. It will be appreciated that specific elements, substructures,advantages, uses, and/or other features of the embodiments describedwith reference to FIGS. 10A-56 can be suitably interchanged, substitutedor otherwise configured with one another and/or with the embodimentsdescribed with reference to FIGS. 57A-71 in accordance with additionalembodiments of the present technology. Furthermore, suitable elements ofthe embodiments described with reference to FIGS. 10A-71 can be used asstand-alone and/or self-contained devices.

Systems, devices and methods are provided herein for percutaneousimplantation of prosthetic heart valves in a heart of a patient. In someembodiments, methods and devices are presented for the treatment ofvalve disease by minimally invasive implantation of artificialreplacement heart valves. In one embodiment, the artificial replacementvalve can be a prosthetic valve device suitable for implantation andreplacement of a mitral valve between the left atrium and left ventriclein the heart of a patient. In another embodiment, the prosthetic valvedevice can be suitable for implantation and replacement of another valve(e.g., a bicuspid or tricuspid valve) in the heart of the patient. FIG.10A shows an isometric view of a prosthetic heart valve device 100 in anexpanded configuration 102 in accordance with an embodiment of thepresent technology, and FIG. 10B is a schematic illustration of across-sectional view of a heart depicting the left atrium, leftventricle, and native mitral valve of the heart. FIG. 10B also shows anembodiment of the expandable prosthetic valve device 100 implanted inthe native mitral valve region of the heart.

As shown in FIG. 10A, the device 100 can include a flexible anchoringmember 110 at least partially surrounding and coupled to an inner valvesupport 120. The device 100 can further include a prosthetic valve 130coupled to, mounted within, or otherwise carried by the valve support120. FIGS. 10C-10F are side, perspective cut-away, top, and bottomviews, respectively, of the prosthetic heart valve device 100 inaccordance with the present technology. The device 100 can also includeone or more sealing members 140 and tissue engaging elements 170. Forexample, the sealing member 140 can, in one embodiment, extend around aninner wall 141 of the anchoring member 110 and/or around an exteriorsurface 127 of the valve support 120 to prevent paravalvular (e.g.,paraprosthetic) leaks between the device 100 and the native tissueand/or between the anchoring member 110 and the valve support 120. Inanother specific embodiment, and as shown in FIG. 10A, the tissueengaging elements 170 can be spikes disposed on an upstream perimeter113 of the anchoring member 110 and extend in an upward and/or radiallyoutward direction to engage, and in some embodiments, penetrate thenative tissue to facilitate retention or maintain position of the devicein a desired implanted location. The tissue engaging elements 170 mayalso be included around an outer wall 142 of the anchoring member 110and can extend outwardly to engage and, in some embodiments, penetratethe native valve leaflets or other adjacent tissue. Additionally, thevalve support 120 can have a plurality of coupling features 180, such aseyelets, around an upstream end 121 to facilitate loading, retention anddeployment of the device 100 within and from a delivery catheter (notshown), as further described herein.

The prosthetic heart valve device 100 can be movable between a deliveryconfiguration (not shown), an expanded configuration 102 (FIG. 10A), anda deployed configuration 104 (FIG. 10B). In the delivery configuration,the prosthetic heart valve device 100 has a low profile suitable fordelivery through small-diameter guide catheters positioned in the heartvia the trans-septal, retrograde, or trans-apical approaches describedherein. In some embodiments, the delivery configuration of theprosthetic heart valve device 100 will preferably have an outer diameterno larger than about 8-10 mm for trans-septal approaches, about 8-10 mmfor retrograde approaches, or about 8-12 mm for trans-apical approachesto the mitral valve MV. As used herein, “expanded configuration” refersto the configuration of the device when allowed to freely expand to anunrestrained size without the presence of constraining or distortingforces. “Deployed configuration,” as used herein, refers to the deviceonce expanded at the native valve site and subject to the constrainingand distorting forces exerted by the native anatomy.

Referring back to FIG. 3, “subannular,” as used herein, refers to aportion of the mitral valve MV that lies on or downstream DN of theplane PO of the native orifice. As used herein, the plane PO of thenative valve orifice is a plane generally perpendicular to the directionof blood flow through the valve and which contains either or both themajor axis MVA1 or the minor axis MVA2 (FIG. 5C). Thus, a subannularsurface of the mitral valve MV is a tissue surface lying on theventricular side of the plane PO, and preferably one that facesgenerally downstream, toward the left ventricle LV. The subannularsurface may be disposed on the annulus AN itself or the ventricular wallbehind the native leaflets LF, or it may comprise a surface of thenative leaflets LF, either inward-facing IF or outward-facing OF, whichlies below the plane PO. The subannular surface or subannular tissue maythus comprise the annulus AN itself, the native leaflets LF,leaflet/annulus connective tissue, the ventricular wall or combinationsthereof.

In operation, the prosthetic heart valve device 100 can beintravascularly delivered to a desired location in the heart, such as anintracardiac location near the mitral valve MV, while in the delivery(e.g., collapsed) configuration within a delivery catheter (not shown).Referring to FIG. 10B, the device 100 can be advanced to a positionwithin or downstream of the native annulus AN where the device 100 canbe released from the delivery catheter to enlarge toward the expandedconfiguration 102 (FIG. 10A). The device 100 will engage the nativetissue at the desired location, which will deform or otherwise alter theshape of the device 100 into the deployed configuration 104 (FIG. 10B).Once released from the catheter, the device 100 can be positioned suchthat at least a portion of the flexible anchoring member 110 engages asubannular surface of the native valve so as to resist systolic forcesand prevent upstream migration of the device 100 (FIG. 10B). In theembodiment illustrated in FIG. 10B, the upstream perimeter 113 of theanchoring member 110 engages the inward-facing surfaces IF (FIG. 3) ofthe native leaflets LF, which are pushed outwardly and folded under thenative annulus AN. The leaflets LF engage a ventricular side of theannulus AN and are prevented from being pushed further in the upstreamdirection, thus maintaining the anchoring member 110 below the plane ofthe native valve annulus. The tissue engaging elements 170 can penetratethe tissue of the leaflets LF and/or the annulus AN to stabilize andfirmly anchor the device 100. In some embodiments, however, someportions of the anchoring member 110 may extend above the annulus AN,with at least some portions of the anchoring member 110 engaging tissuein a subannular location to prevent migration of the device 100 towardthe left atrium LA. As shown in FIG. 10B, the leaflets LF can lie inapposition against the outer wall 142 of the anchoring member 110forming a blood-tight seal with the sealing member 140. The tissueengaging elements 170 can apply pressure against or, in anotherembodiment, penetrate the annulus AN or leaflets LF along the outer wall142 of the anchoring member 110 to further stabilize the device 100 andprevent migration.

In accordance with aspects of the present technology, the proximal orupper end of the anchoring member 110, while in a deployed configuration104, conforms to the irregularly-shaped mitral annulus AN, effectivelysealing the device 100 against the native annulus AN to anchor thedevice and to prevent paravalvular leaks. As described further herein,the anchoring member 110 mechanically isolates the valve support 120from distorting forces present in the heart such that the anchoringmember 110 may adapt and/or conform to native forces while the valvesupport 120 maintains its structural integrity. Accordingly, theanchoring member 110 can be sufficiently flexible and resilient and/orcoupled to the valve support 120 in such a manner as to mechanicallyisolate the valve support 120 from the forces exerted upon the anchoringmember 110 by the native anatomy. Alternatively, or in addition to theabove features, the valve support 120 may be more rigid and/or havegreater radial strength than the radial strength of the anchoring member110 so as to maintain its cylindrical or other desired shape and toensure proper opening and closing of the prosthetic valve 130 housedwithin the valve support structure 120. In some embodiments, the valvesupport 120 has a radial strength of at least 100%, or in otherembodiments at least 200%, and in further embodiments at least 300%,greater than a radial strength of the anchoring member 110. In oneembodiment, the valve support 120 can have a radial strength ofapproximately 10 N to about 12 N. Thus, if deformed from its unbiasedshape by exerting a radially compressive force against itscircumference, the valve support 120 can exhibit a hoop force which isabout 2 to about 20 times greater for a given degree of deformation thanwill be exhibited by the anchoring member 110.

As illustrated in FIGS. 10A-10F, the anchoring member 110 has adownstream portion 111 and an upstream portion 112 opposite thedownstream portion 111 relative to a longitudinal axis 101 of the device100. The upstream portion 112 of the anchoring member 110 can be agenerally outward oriented portion of the device 100, as shown in FIG.10D. In one embodiment the anchoring member 110 has a generallyhyperboloidic shape, such as the shape of a two-sheet hyperboloid. Inanother example, the downstream portion 111 can be substantiallycircular in cross-section while the upstream portion 112 can begenerally non-circular. In some embodiments, the anchoring member 110can include a series of circumferentially positioned, resilientlydeformable and flexible longitudinal ribs 114 which, in someembodiments, are connected circumferentially by deformable and/orflexible connectors 116. Once deployed, at least a portion of theupstream ends of the longitudinal ribs 114 engage a subannular surfaceof the native valve (e.g., mitral valve). As described in more detailbelow, certain embodiments of longitudinal ribs 114 are configured topenetrate subannular tissue to anchor and further stabilize the device100.

Additionally, FIGS. 10A-10F also illustrate that the longitudinal ribs114 and/or circumferential connectors 116 may be arranged in a varietyof geometrical patterns. In the examples shown in FIGS. 10A-10F, theconnectors 116 are formed in a chevron configuration. One of ordinaryskill will recognize that diamond-shaped patterns, sinusoidalconfigurations, closed cells, open cells, or other circumferentiallyexpandable configurations are also possible. In some embodiments, thelongitudinal ribs 114 may be divided along their length into multiple,separated segments (not shown), e.g. where the connectors 116interconnect with the longitudinal ribs 114. The plurality of connectors116 and ribs 114 can be formed from a deformable material or from aresilient or shape memory material (e.g., Nitinol). In otherembodiments, the anchoring member 110 can comprise a mesh or wovenconstruction in addition to or in place of the longitudinal ribs 114and/or circumferential connectors 116. For example, the anchoring member110 could include a tube or braided mesh formed from a plurality offlexible wires or filaments arranged in a diamond pattern or otherconfiguration. In another example, a metal tube can be laser cut toprovide a desired rib or strut geometry. The diamond configuration can,in some embodiments, provide column strength sufficient to inhibitmovement of the device 100 relative the annulus under the force ofsystolic blood pressure against the valve 130 mounted in the valvesupport 120. In a particular example, the anchoring member 120 can beformed of a preshaped Nitinol tube having, for example, a wall thicknessof approximately 0.010 inches to about 0.030 inches.

FIGS. 11A-11H show several embodiments of valve supports 120 that can beused in embodiments of the prosthetic heart valve device 100 shown inFIGS. 10A-10F. FIGS. 11A-11G are side and isometric views of the valvesupport 120 shown in an expanded configuration 102, and FIG. 11H is anisometric view of another embodiment of a prosthetic heart valve device100 disposed in an expanded configuration 102 in accordance with thepresent technology. Referring to FIGS. 10A-10F and 11A-11H together,several embodiments of the valve support 120 can be generallycylindrical having an upstream end 121 and a downstream end 123 formedaround a longitudinal axis 101 with a circular, oval, elliptical,kidney-shaped, D-shaped, or other suitable cross-sectional shapeconfigured to support a tricuspid or other prosthetic valve 130. In someembodiments, the valve support 120 includes a plurality of posts 122connected circumferentially by a plurality of struts 124. The posts 122and struts 124 can be arranged in a variety of geometrical patterns thatcan expand and provide sufficient resilience and column strength formaintaining the integrity of the prosthetic valve 130. For example, theplurality of posts 122 can extend longitudinally across multiple rows ofstruts 124 to provide column strength to the valve support 120. However,in other embodiments, the valve support 120 can include a metallic,polymeric, or fabric mesh or a woven construction.

Generally, the plurality of posts 122 can extend along an axialdirection generally parallel to the longitudinal axis 101 and the struts124 can extend circumferentially around and transverse to thelongitudinal axis 101. The posts 122 can extend an entire longitudinalheight H₁ of the valve support 120 (FIG. 11A), or in another embodiment,the posts 122 can include a plurality of independent and separate postsegments (not shown) along the valve support height H₁. In oneembodiment the height H₁ can be approximately 14 mm to about 17 mm. Thestruts 124 can form a series of rings around the longitudinal axis 101,wherein each ring has a circumferentially expandable geometry. In theexample shown in FIGS. 11A, 11D and 11H, the struts 124 are formed in aseries of zig-zags and arranged in pairs 180 degrees out of phase witheach other so as to form a series of diamonds. Alternative expandablegeometries can include sinusoidal patterns, chevron configurations (FIG.11B), closed cells (FIG. 11C), open cells, or other expandableconfigurations. The plurality of struts 124 can attach to the pluralityof posts 122 so as to define a plurality of nodes 125 where the strutsand posts intersect. The plurality of struts 124 and the plurality ofposts 122 can be formed from a deformable material or a resilient orshape memory material (e.g., Nitinol).

The anchoring member 110 and the valve support 120 may be made of thesame or, in some embodiments, different materials. In some embodiments,both the anchoring member 110 and the valve support 120 include aresilient biocompatible metal, such as stainless steel, nickel cobalt orcobalt chromium alloys such as MP35N, or nickel titanium alloys such asNitinol. Superelastic shape memory materials such as Nitinol can allowthe device to be collapsed into a very low profile deliveryconfiguration suitable for delivery through the vasculature viacatheter, and allow self-expansion to a deployed configuration suitablysized to replace the target valve. In some embodiments, the anchoringmember 110 and/or the valve support 120 can be laser cut from a singlemetal tube into the desired geometry, creating a tubular scaffold ofinterconnected struts. Anchoring member 110 may then be shaped into adesired configuration, e.g. a flared, funnel-like or hyperboloid shape,using known shape-setting techniques for such materials.

As shown in FIGS. 11B-11E, the valve support 120 has an interior surface126 and an exterior surface 127, and the valve support 120 is configuredto receive or support the prosthetic valve 130 within an interior lumenof the valve support 120 to inhibit retrograde blood flow (e.g., bloodflow from the left ventricle into the left atrium). Accordingly, thevalve support 120 can provide a scaffold to which prosthetic valvetissue can be secured and provide a scaffold that has sufficient axialrigidity to maintain a longitudinal position of the prosthetic valve 130relative to the anchoring member 110. The valve support 120 can furtherprovide such a scaffold having radial rigidity to maintain circularity(or other desired cross-sectional shape) to ensure that leaflets 132 ofthe prosthetic valve 130 coapt or otherwise seal when the device 100 issubject to external radial pressure. In one embodiment, the valvesupport 120 can have a support region 145 along the longitudinal axis101 that is configured to attach to the prosthetic valve, or in otherembodiments, be aligned with the coaptation portion of the leaflets 132(shown in FIG. 11B).

The valve 130 may comprise a temporary or permanent valve adapted toblock blood flow in the upstream direction and allow blood flow in thedownstream direction through the valve support 120. The valve 130 mayalso be a replacement valve configured to be disposed in the valvesupport 120 after the device 100 is implanted at the native mitralvalve. The valve 130 can have a plurality of leaflets 132, and may beformed of various flexible and impermeable materials including PTFE,Dacron®, pyrolytic carbon, or other biocompatible materials or biologictissue such as pericardial tissue or xenograft valve tissue such asporcine heart tissue or bovine pericardium. Other aspects of valve 130are described further below. The interior surface 126 within the lumenof the valve support 120 can be covered at least partially by animpermeable sealing member 140 to prevent blood flow from inside thevalve support 120 to the outside of the valve support 120, where itcould leak around the exterior of the valve support 120. In anotherembodiment, the sealing member 140 may be affixed to the exteriorsurface 127 of the valve support 120 and, in either embodiment, may beintegrally formed with or attached directly to valve 130. In anadditional embodiment, the sealing member 140 can be applied on at leastportions of both the interior surface 126 and the exterior surface 127of the valve support 120.

As shown in FIGS. 11B-11H, the prosthetic valve 130 can be sutured,riveted, glued, bonded, mechanically interlocked, or otherwise fastenedto posts 122 or commissural attachment structures 128, which areconfigured to align with valve commissures C. The posts 122 orcommissural attachment structures 128 can include eyelets 129, loops, orother features formed thereon to facilitate attachment of sutures orother fastening means to facilitate attachment of the prosthetic valve130. In one embodiment, shown in FIG. 11B, the attachment structures 128can be integrated into the structural frame of the valve support 120such that the attachment structures 128 are distributed around thecircumference of the valve support 120 and function as posts 122. Inanother embodiment, shown in FIG. 11D, the attachment structures 128 canbe attachment pads formed on parts of the posts 122 (e.g., along anupper end of the posts 122). In the embodiments illustrated in FIGS.11E-11G, the valve support 120 includes support bands 119 to which theattachment structures 128 are incorporated. In one embodiment, theattachment structures 128 can be integral with the support bands 119(e.g., laser cut from a single metal tube into the desired geometry,creating one or more tubular support bands having interconnected strutswith longitudinal attachment structures). In other embodiments, thesupport bands 119 can be separate component that are fastened to theattachment structures 128. In a further embodiment, shown in FIG. 11H,the attachment structures 128 can be separate structures that can becoupled to posts 122, struts 124 or other components along the interiorsurface 126 of the valve support 120.

As illustrated in FIG. 11C, the prosthetic valve 130 may also beattached to the sealing member 140 or sleeve which is attached to theinterior surface 126 of the valve support 120, as described above. Onceattached, the prosthetic valve 130 can be suitable to collapse orcompress with the device 100 for loading into a delivery catheter (notshown). In one embodiment, the prosthetic valve 130 has a tri-leafletconfiguration, although various alternative valve configurations may beused, such as a bi-leaflet configuration. The design of the prostheticvalve 130, such as the selection of tri-leaflet vs. bi-leafletconfigurations, can be used to determine the suitable shape of the valvesupport 120. For example, for a tri-leaflet valve, the valve support 120can have a circular cross-section, while for a bi-leaflet valve,alternative cross-sectional shapes are possible such as oval or D-shapedcross-sections. In particular examples, the valve support can have acircular cross-sectional diameter of approximately 25 mm to about 32 mm,such as 27 mm.

In some arrangements, the valve support 120 can have a permanentprosthetic valve pre-mounted therein, or the valve support 120 may beconfigured to receive a separate catheter-delivered valve followingimplantation of the device 100 at the native mitral valve. Inarrangements where a permanent or replacement valve is desirable, thevalve support 120 can further include a temporary valve pre-mountedwithin the interior lumen. If a period of time between placement of thedevice 100 and further implantation of the permanent prosthetic valve isdesirable, a temporary valve sewn into or otherwise secured within thevalve support 120 can assure regulation of blood flow in the interim.For example, temporary valves may be used for a period of about 15minutes to several hours or up to a several days. Permanent orreplacement prosthetic valves may be implanted within a temporary valveor may be implanted after the temporary valve has been removed. Examplesof pre-assembled, percutaneous prosthetic valves include, e.g., theCoreValve ReValving® System from Medtronic/Corevalve Inc. (Irvine,Calif., USA), or the Edwards-Sapien® valve from Edwards Lifesciences(Irvine, Calif., USA). If adapted to receive a separatecatheter-delivered valve, the valve support 120 may have features withinits interior lumen or on its upper or lower ends to engage and retainthe catheter-delivered valve therein, such as inwardly extending ridges,bumps, prongs, or flaps. Additional details and embodiments regardingthe structure, delivery and attachment of prosthetic valves, temporaryvalves and replacement valves suitable for use with the prosthetic heartvalve devices disclosed herein can be found in International PCT PatentApplication No. PCT/US2012/043636, entitled “PROSTHETIC HEART VALVEDEVICES AND ASSOCIATED SYSTEMS AND METHODS,” filed Jun. 21, 2012, theentire contents of which are incorporated herein by reference.

In some arrangements, the anchoring member 110 is defined by a structureseparate from the valve support 120. For example, the anchoring member110 can be a first or outer frame or skeleton and the valve support 120can be a second or inner frame or skeleton. As such, the anchoringmember 110 can at least partially surround the valve support 120. Insome embodiments, the downstream portion 111 of the anchoring member 110can be coupled to the valve support 120 while the upstream portion 112is not connected or coupled to the valve support 120 in a manner thatunduly influences the shape of the valve support 120. For example, insome embodiments, the upstream portion 112 of the anchoring member 110can be configured to engage and deform to the shape of the native tissueon or under the annulus while the cross-sectional shape of the valvesupport 120 remains sufficiently stable. For example, the valve support120 (e.g., at least at the upstream end 121) can be spaced radiallyinward from the upstream portion 112 of the anchoring member 110 suchthat if the anchoring member 110 is deformed inwardly, at least theupstream end 121 of the valve support 120 remains substantiallyundeformed. As used herein, “substantially undeformed” can refer tosituations in which the valve support 120 is not engaged or deformed, orcan refer to scenarios in which the valve support 120 can deformslightly but the prosthetic valve 130 remains intact and competent(e.g., the leaflets 132 coapt sufficiently to prevent retrograde bloodflow). In such arrangements, leaflets 132 of the prosthetic valve 130can close sufficiently even when the device 100 is under systolicpressures or forces from the pumping action of the heart.

The longitudinal ribs 114 and/or circumferential connectors 116 can beless rigid than the posts 122 and/or struts 124 of the valve support120, allowing greater flexibility in the anchoring member 110 and/ormore stability to the shape and position of the valve support 120. Insome embodiments, the flexibility of the anchoring member 110 can allowthe anchoring member 110 to absorb distorting forces as well as allowthe device 100 to conform to the irregular, non-circular shape of thenative annulus (while leaving the valve support 120 substantiallyunaffected), encouraging tissue ingrowth and creating a seal to preventleaks between the device 100 and the native tissue. In addition, thelongitudinal ribs 114 and/or connectors 116 can be configured to pressradially outward against the native valve, ventricular and/or aorticstructures so as to anchor the device 100 in a desired position, as wellas maintain an upstream deployed circumference 150′ larger than that ofthe native annulus such that subannular positioning effectively preventsupstream migration of the device 100 (described further below in FIG.14C). Furthermore, the longitudinal ribs 114 can have sufficientresilience and column strength (e.g., axial stiffness) to preventlongitudinal collapse or eversion of the anchoring member 110 and/or thedevice 100 and to resist movement of the device in an upstreamdirection.

By structurally separating the anchoring member 110 from the valvesupport 120, the valve 130 and valve support 120 are effectivelymechanically isolated from the distorting forces exerted on theanchoring member 110 by the native tissue, e.g., radially compressiveforces exerted by the native annulus and/or leaflets, longitudinaldiastolic and systolic forces, hoop stress, etc. For example,deformation of the anchoring member 110 by the native tissue can changea cross-section of the anchoring member 110 (e.g., to a non-circular ornon-symmetrical cross-section), while the valve support 120 may besubstantially undeformed. In one embodiment, at least a portion of thevalve support 120 can be deformed by the radially compressive forces,for example, where the anchoring member 110 is coupled to the valvesupport 120 (e.g., the downstream end 123). However, the upstream end121 of the valve support 120 and/or the valve support region 145 (FIG.11B) is mechanically isolated from the anchoring member 110 and thecompressive forces such that at least the valve support region 145 canbe substantially undeformed. Thus the valve support 120, and at leastthe valve support region 145, can maintain a circular or other desirablecross-section so that the valve remains stable and/or competent. Theflexibility of the longitudinal ribs 114 can contribute to theabsorption of the distorting forces, and also aid in mechanicallyisolating the valve support 120 and valve 130 from the anchoring member110.

At an upstream end of the device 100 oriented toward the left atrium,the valve support 120 can be configured to sit below, even with, orabove the uppermost terminal of the upstream portion 112 of theanchoring member 110. At a downstream end of the device 100 orientedtoward and residing within the left ventricle, the anchoring member 110can be coupled to the valve support 120. Alternatively, the anchoringmember 110 can be coupled to the valve support 120 anywhere along alength of the valve support 120. The valve support 120 and anchoringmember 110 may be coupled by a variety of methods known in the art,e.g., suturing, soldering, welding, staples, rivets or other fasteners,mechanical interlocking, friction, interference fit, or any combinationthereof. In other embodiments, the valve support 120 and the anchoringmember 110 can be integrally formed with one another. In yet anotherembodiment, a sleeve or other overlaying structure (not shown) may beattached to both the anchoring member 110 and the valve support 120 tointerconnect the two structures.

FIGS. 12A-12C are side views of various longitudinal ribs 114 flexing inresponse to a distorting force F in accordance with further embodimentsof the present technology. The degree of flexibility of individuallongitudinal ribs 114 (and thus the anchoring member 110) may beconsistent among all ribs of an anchoring member 110, or, alternatively,some ribs 114 may be more flexible than other ribs 114 within the sameanchoring member 110. Likewise, a degree of flexibility of individualribs 114 may be consistent throughout an entire length of the rib 114 orthe degree of flexibility can vary along the length of each rib 114.

As shown FIGS. 12A-12C, the longitudinal ribs 114 (shown individually as114A-114C) may flex along their respective lengths in response todistorting forces F that can be applied by the surrounding tissue duringor after implantation of the device 100. In FIG. 12A, the rib 114A mayflex downward to a position 75′ or upward to a position 75″ in responseto an upward or downward force F₁, respectively. Similarly, in FIG. 12B,a rib 114B with multiple distinct segments 85A, 85B, 85C may flex and/orrotate inwardly/outwardly or side-to-side in response to alaterally-directed force F₂. The distinct segment 85A at the end of therib 114B may flex and/or rotate inwardly/outwardly or side-to-side(e.g., to position 85A′) in response to the laterally directed force F₂separate from lower distinct segments 85B and 85C. In otherarrangements, the segment 85A may flex and/or rotate (e.g., to position85AB′) with the distinct segment 85B or with both segments 85B and 85Ctogether (not shown). As shown in FIG. 12C, the rib 114C having agenerally linear shape when in a relaxed state, may also flex and/orrotate inwardly/outwardly or side-to-side (e.g., to positions 95′ or95″) in response to a laterally-directed force F₃, by bending to createa curved shape, or in another embodiment not shown, by bending so as tocreate two substantially linear segments.

Individual ribs 114 can also have a variety of shapes and be placed in avariety of positions around a circumference of the anchoring member 110.In some embodiments, the device 100 can include a first and secondplurality of ribs wherein the first plurality of ribs have acharacteristic different than the second plurality of ribs. Variouscharacteristics could include size of the rib, rib shape, rib stiffness,extension angle and the number of ribs within a given area of theanchoring member. In other embodiments, the longitudinal ribs can beunevenly or evenly spaced around an outer perimeter of the anchoringmember,

The ribs 114 can be positioned around a circumference oriented along thelongitudinal axis 101 of the anchoring member 110 to create any numberof overall cross-sectional geometries for the anchoring member 110,e.g., circular, D-shaped, oval, kidney, irregular, etc. FIG. 13A is aschematic, cross-sectional view of a prosthetic heart valve device inaccordance with another embodiment of the present technology, and FIGS.13B-13F are partial side views of prosthetic heart valve devicesillustrating a variety of longitudinal rib configurations in accordancewith additional embodiments of the present technology. Referring to FIG.13A, an individual rib 114 can comprise a plurality of linear segments,such as segments 85A and 85B. In the illustrated example, the ribsegment 85B is angled radially outwardly (e.g., angled away from thelongitudinal axis 101) by a first angle A₁. The rib segment 85B extendsin an upstream direction from its point of attachment to the valvesupport 120 at the downstream end of the segment 85B, thereby giving theanchoring member 110 a conical or flared shape, with a larger diameterD₂ at the upstream portion 112 and a smaller diameter D₃ at thedownstream portion 111 of the anchoring member 110. In one embodiment,the upper rib segment 85A can be angled at a steeper second angle A₂relative to the longitudinal axis 101 than lower rib segment 85B,resulting in a wider flared upstream portion 112A at the upstreamportion 112 of the anchoring member 110. In some arrangements, the widerflared upstream portion 112A may enhance sealing between the anchoringmember 110 and the native tissue, while the downstream portion 111 canprovide a more rigid geometry for resisting upstream movement of thedevice 100 when systolic forces are exerted on the device 100.Alternatively, the rib 114 can be arcuate over all or a portion of itslength, as shown in the partial side view of FIG. 13B.

In yet other embodiments, as illustrated by FIGS. 13C-13F, the rib 114can have a more complex shape defined by multiple distinct segments 85A,85B, 85C, etc. For example, as shown in FIG. 13C, the rib 114 includes alinear rib segment 85C generally parallel to the longitudinal axis 101connected at its upstream end to a linear and radially outwardlyextending rib segment 85B, where rib segment 85B is connected at itsupstream end to a more vertical rib segment 85A which is about parallelwith the longitudinal axis 101. Referring to FIG. 13D, the rib 114 caninclude a linear rib segment 85B generally parallel to longitudinal axis101 and connected at its upstream end to a linear and radially outwardlyextending rib segment 85A, which is generally perpendicular tolongitudinal axis 101. Referring to FIG. 13E, the rib 114 can include alinear rib segment 85C generally parallel to the longitudinal axis 101and connected at its upstream end to a linear and radially outwardlyextending rib segment 85B which is generally perpendicular to thelongitudinal axis 101. The rib segment 85B can further be connected atits most radially outward end to a vertical rib segment 85C generallyparallel with the longitudinal axis 101. In reference to FIG. 13F, therib 114 includes a linear segment 85D generally parallel with thelongitudinal axis 101 and connected at its upstream end to a radiallyoutwardly extending segment 85C which is generally perpendicular to thelongitudinal axis 101. The rib segment 85C can further be connected atits most radially outward end to a linear, vertical segment 85Bgenerally parallel with the longitudinal axis 101, and where 85B isconnected at its most radially outward end to a linear and radiallyinward extending segment 85A.

In the embodiments illustrated in FIGS. 13C-13F, the ribs 114 can becoupled to the valve support 120 (e.g., coupled to posts 122) in amanner to enhance mechanical isolation of the valve support 120. Forexample, the ribs 114 may be attached to the valve support 120 near thedownstream end of the ribs 114 such that a substantial portion of eachrib 114 upstream of the attachment point is movable and deformablerelative to the valve support 120, thereby allowing the rib 120 to flexradially outward or circumferentially back and forth relative to thevalve support 120. Additionally, one of ordinary skill in the art willrecognize that in any of the embodiments illustrated in FIGS. 13A-13F,any or all of the rib segments may have a curvature, and anyinterconnections of segments shown as angled may instead be curved.Accordingly, any of these various geometries may be configured to allowthe anchoring member 110 to conform to the native anatomy, resistmigration of the device 100, and mechanically isolate the valve support120 and/or the prosthetic valve 130 contained therein from forcesexerted on the anchoring member 110 by the native tissue.

The flexible characteristics of the individual ribs 114 can allow forthe flexibility and conformability of the anchoring member 110 to engageand seal the device 100 against uneven and uniquely-shaped nativetissue. Additionally, the flexibility can assist in creating a sealbetween the device 100 and the surrounding anatomy. FIG. 14A is aschematic top view of a native mitral valve MV illustrating the minoraxis 50 and major axis 55, and FIGS. 14B-14C are schematic top views ofan anchoring member 110 in an expanded configuration 102 and in adeployed configuration 104, respectively, overlaying the schematic ofthe native mitral valve MV in accordance with an embodiment of thepresent technology.

Referring to FIG. 14B, the upstream portion 112 (FIG. 10A) of theanchoring member 110 can have an outer circumference 150 with a diameterD₁ that is greater than the minor axis 50 (FIG. 14A) of the nativeannulus, and usually less than the major axis 55 of the annulus, whenthe anchoring member 110 is in an expanded configuration 102 (shown asdashed lines). In other embodiments, the anchoring member 110 may have adiameter D₁ at least as large as the distance between the nativecommissures C, and may be as large as or even larger than the major axis55 of the native annulus. In some embodiments, the outer circumference150 of the anchoring member 110 has the diameter D₁ which isapproximately 1.2 to 1.5 times the diameter (not shown) of the valvesupport 120 (or the prosthetic valve 130), and can be as large as 2.5times the diameter of the valve support 120 (or the prosthetic valve130). While conventional valves must be manufactured in multiple sizesto treat diseased valves of various sizes, the valve support 120 and theprosthetic valve 130, in accordance with aspects of the presenttechnology, may be manufactured in just a single diameter to fit amultitude of native valve sizes. For example, the valve support 120 andthe prosthetic valve 130 do not need to engage and fit the nativeanatomy precisely. In a specific example, the valve support 120 may havea diameter (not shown) in the range of about 25 mm to about 32 mm foradult human patients. Also in accordance with aspects of the presenttechnology, the anchoring member 110 may be provided in multiplediameters to fit various native valve sizes, and may range in diameterat an upstream end from about 28 mm to about 80 mm, or in otherembodiments, greater than 80 mm.

The top view of the anchoring member 110 shown in FIG. 14C illustrateshow flexibility and/or deformation of one or more longitudinal ribs 114and/or rib segments allows the anchoring member 110 to distort relativeto the expanded configuration 102, as shown by the dashed lines, into adeployed configuration 104, as shown by the bolded lines. As shown inFIG. 14C, the anchoring member 110, when deployed or implanted at orunder the mitral valve annulus, can conform to the highly variablenative mitral valve tissue shape MV, as shown in the dotted lines, whilethe ribs 114 bend, twist, and stretch such that the overall shape of theanchoring member 110 has a deployed (e.g., a generally more oval orD-shaped, or other irregular shape) configuration 104 instead of a fullyexpanded configuration 102. Referring to FIGS. 14B-14C together, theanchoring member 110 covers the mitral valve commissures C in thedeployed configuration 104, whereas the commissures C would be leftunsealed or exposed in the more circular expanded configuration 102,potentially allowing paravalvular leaks. The anchoring member 110 couldalso be pre-shaped to be in a generally oval or D-shape, or other shape,when in an unbiased condition.

FIG. 15 is an isometric view of an embodiment of the prosthetic heartvalve device 100 illustrated in a deployed configuration 104 inaccordance with an embodiment of the present technology. FIG. 15illustrates the device 100 having a plurality of ribs 114, wherein afirst set of ribs 160 can be configured to bend inwards or compresstoward the center longitudinal axis 101 of the device 100 and a secondset of ribs 162 can be configured to bend outwards or flex in responseto an distorting forces present in a subannular space of the nativevalve. As a result, the outer circumference 150 of the anchoring member110 may distort from a more circular shape in the expanded configuration102, as shown by the dashed line, to a generally more oval or D-shape inthe expanded configuration 104, as shown by the solid line, thusconforming to the shape of the native anatomy. In a further arrangement,the upstream portion 112 of the anchoring member 110 may be sizedslightly larger than the subannular space into which it is deployed,such that the anchoring member 110 is compressed to a slightly smallerdiameter in its deployed configuration 104. This may cause a slightrelaxation of the sealing member 142, such that sealing member sectionsbetween adjacent ribs 114 are sufficiently slack to billow or curveinwards or outwards to form a slack section Bi, as shown in FIG. 15.Such billowing can be desirable in some arrangements because thecurvature of the relaxed sleeve segment Bi can engage and conform to themitral leaflet tissue, thereby enhancing a seal formed between thedevice 100 and the native tissue.

As shown in FIG. 15, the unbiased, expanded configuration of the valvesupport 120, which in the illustrated embodiment is circular incross-section, remains substantially unaffected while the anchoringmember 110 conforms to the non-circular shape of the native mitral valveannulus MV. Accordingly, the valve support 120 is mechanically isolatedfrom these forces and maintains its structural shape and integrity. Themechanical isolation of the valve support 120 from the anchoring member110 may be attributed to several aspects of the prosthetic heart valvedevice 100. For example, the relative high flexibility of the anchoringmember 110 compared with the lower flexibility of the valve support 120allows the anchoring member 110 to deform significantly when deployedand when in operation (e.g., conform to the shape and motion of theanatomy under ventricular systole forces) while the valve support 120remains substantially undeformed (e.g., generally circular) in thesesame conditions. Additionally, radial spacing between the anchoringmember 110 and the valve support 120, particularly at the upstreamportion/upstream end where the anchoring member 110 engages the nativeannulus and/or subannular tissue, allows the anchoring member 110 to bedeformed inwardly a substantial amount without engaging the valvesupport 110. Further, the anchoring member 110 can be coupled to thevalve support 120 at a location (e.g. the downstream portion 111 of theanchoring member 110) which is spaced apart longitudinally a substantialdistance from the location (e.g., the upstream portion 112 of theanchoring member 110) at which the anchoring member 110 engages thenative annulus, allowing the ribs 114 of the anchoring member 110 toabsorb much of the distorting forces exerted upon it rather thantransmitting those forces directly to the valve support 120. Moreover,the coupling mechanisms employed to attach the anchoring member 110 tothe valve support 120 can be configured (e.g., to be flexible ormoveable) so as to reduce the transmission of forces from the anchoringmember 110 to the valve support 120 (discussed in more detail herein).

In many embodiments, the anchoring member 110 can have sufficientflexibility such that the anchoring member 110 conforms to the nativemitral annulus when in the deployed configuration 104 (FIGS. 14C and15); however, the anchoring member 110 can be configured to remainbiased towards its expanded configuration 102 (e.g., FIGS. 10A and 14B)such that, when in the deployed configuration 104, the anchoring member110 pushes radially outwards against the native annulus, leaflets,and/or ventricular walls just below the annulus. In some arrangements,the radial force generated by the biased anchoring member shape may besufficient to deform the native anatomy such that the minor axis 50(FIG. 14A) of the native valve is increased slightly, and/or the shapeof the annulus is otherwise altered. Such radial force can enhanceanchoring of the device 100 to resist movement toward the atrium whenthe valve 130 is closed during ventricular systole as well as movementtoward the ventricle when the valve 130 is open. Furthermore, theresulting compression fit between the anchoring member 110 and leafletsand/or ventricular walls or other structures helps create a long-termbond between the tissue and the device 100 by encouraging tissueingrowth and encapsulation.

FIGS. 16A-17C illustrate a prosthetic heart valve device 100 configuredin accordance with additional embodiments of the present disclosure.FIGS. 16A-16C include a top view and first and second side views of aprosthetic heart valve device 100 illustrated in an expandedconfiguration 102 that includes features generally similar to thefeatures of the prosthetic heart valve device 100 described above withreference FIGS. 10A-15. For example, the device 100 includes the valvesupport 120 and the prosthetic valve 130 housed within an interior lumenof the valve support 120. However, in the embodiment shown in FIGS.16A-16C, the device 100 includes an anchoring member 210 having an ovalor D-shaped upstream perimeter 213 and a plurality of elevations arounda circumference 250 of the anchoring member 210 such that the anchoringmember 210 is suitable for engaging and conforming with tissue in thesubannular region of the mitral valve.

Referring to FIGS. 16A-16C together, the device 100 can include theflexible anchoring member 210 at least partially surrounding and coupledto the valve support 120 at a downstream portion 211 of the anchoringmember 210. The device 100 can also include one or more sealing members140 extending around an inner wall 241 of the anchoring member 210and/or around the exterior surface 127 or the interior surface 126 ofthe valve support 120 to prevent paravalvular leaks between the device100 and the native tissue and/or between the anchoring member 210 andthe valve support 120. In one embodiment, the sealing member 140 canwrap around and/or cover the upstream perimeter 213 of the anchoringmember 210. For example, the sealing member 140 can be sewn, sutured, oradhered to a wall 241, 242 and have an extended portion (not shown) thatfolds over the upstream perimeter 213. In one embodiment, the sealingmember 140 can be adhered to an opposite wall (e.g., extend from theinner wall 241 to cover the upstream perimeter 213 and attached to anupper portion of the outer wall 242). However, in other embodiments, thesealing member 140 can have a longer free edge (not shown) leftunattached. The free edge of the sealing member 140 can be suitable insome arrangements to inhibit blood flow between the upper perimeter 213and the native tissue.

As illustrated in FIGS. 16B-16C, the anchoring member 210 has thedownstream portion 211 and an upstream portion 212 opposite thedownstream portion 111 along a longitudinal axis 201 of the device 100.Similar to the anchoring member 110 of device 100 (FIG. 10A), theupstream portion 212 of the anchoring member 210 can be a generallyoutward oriented portion of the device 100. In some embodiments, theanchoring member 110 can include of a series of circumferentiallypositioned, resiliently deformable and flexible ribs 214 which can be ina crisscross pattern around the circumference 250 of the anchoringmember 210 to form a diamond pattern. In one embodiment, the ribs 214can be flexible wires or filaments arranged in a diamond pattern orconfiguration. The diamond configuration, in some embodiments, provideshoop strength sufficient to provide a frictional attachment to thenative annulus and leaflet tissue to inhibit movement of the device 100relative the annulus under the force of systolic blood pressure againstthe valve 130 mounted in the valve support 120. In a particular example,the anchoring member 120 can be formed of a preshaped Nitinol tubehaving, for example, a wall thickness of approximately 0.010 inches toabout 0.030 inches. The diamond pattern or configuration can, forexample, include one or more rows of diamonds, and in some embodiments,between approximately 12 and approximately 36 columns of diamonds aroundthe circumference 250 of the anchoring member 210.

In some embodiments, the upstream perimeter 213 of the anchoring member210 does not lie in a single plane. For example, the ribs 214 can havevariable lengths and/or be off-set from each other at variable anglessuch that a distance (e.g., elevation) between a downstream perimeter215 and the upstream perimeter 213 can vary around the circumference250. For example, the upstream perimeter 213 can form a rim having aplurality of peaks 251 and valleys 252 (FIG. 16B) for adapting to theshape of the native mitral valve (see FIG. 5C). As used herein, “peaks”and “valleys” do not refer to diamond peaks and diamond valleys of adiamond pattern formed by the plurality of ribs 214, but refers toportions of the upstream perimeter 213 having an undulating shape formedby changes in elevation with respect to the downstream perimeter 215. Inone embodiment, the distance between the downstream perimeter 215 andthe upstream perimeter (e.g., elevation) can vary from about 6 mm toabout 20 mm, and in another embodiment, between about 9 mm and about 12mm.

In one embodiment, the upstream perimeter 213 of the anchoring member210 can have two peaks 251 that are separated by two valleys 252. Insome embodiments, a first peak can have a different shape or elevationthan that of a second peak. In other embodiments, the shape of a valley252 can be different than a shape of an inverted peak 251. Accordingly,the peaks 251 and valleys 252 can be asymmetrically positioned andshaped around the circumference 250 of the anchoring member 210. Invarious arrangements, the valleys 252 can be configured for positioningalong commissural regions of the native annulus, and the peaks 251 canbe configured for positioning along leaflet regions of the nativeannulus. In one embodiment, the peaks 251 can have apices configured tobe positioned near midpoint regions of the leaflets. The anchoringmember might also be circumferentially symmetric when in theunconstrained position, but form the aforementioned “peaks and valleys”when deployed in a non-circular annulus, so that the more radiallyexpanded portions, typically corresponding to the commissures, are lowerthan the less expanded areas, near the centers of the leaflets. Such aneffect might be facilitated by the specific geometry of the ribs anddiamond patterns of the anchoring member.

Referring to FIGS. 17A-17C, one specific example of the anchoring member210 can have a first elevation E₁ between the downstream perimeter 215and the upstream perimeter 213 of approximately 7 mm to about 8 mm atfirst and second regions 253, 254 of the anchoring member. The first andsecond regions 253, 254 are configured to align with the first andsecond commissures (e.g., anterolateral commissure AC and posteromedialcommissure PC, FIG. 5A) of the native mitral valve. The anchoring member210 can also have a second elevation E₂ between the downstream perimeter215 and the upstream perimeter 213 of approximately 9 mm to about 11 mmat a third region 255 of the anchoring member 210, wherein the thirdregion 255 is configured to align with an anterior leaflet AL (FIG. 5A)of the native mitral valve. The anchoring member 210 can further have athird elevation E₃ between the downstream perimeter 215 and the upstreamperimeter 213 of approximately 12 mm to about 13 mm at a fourth region256 of the anchoring member 210 opposite the third region 255, whereinthe fourth region 256 is configured to align with a posterior leaflet PL(FIG. 5A) of the native mitral valve. One of ordinary skill in the artwill recognize that the elevations E₁, E₂ and E₃ can have othermeasurements, and in some embodiments, the elevations E₁, E₂ and E₃ canbe different from one another or the same.

Additionally, the upstream perimeter 213 can form a rim having agenerally oval or D-shape, or other irregular shape for adapting to theshape of the native mitral valve. For example, and referring to FIG.17A, the upstream perimeter 213 of the anchoring member 210 can have amajor perimeter diameter D_(m1) and a minor perimeter diameter D_(m2)perpendicular to the major perimeter diameter D_(m1). In one embodiment,the major perimeter diameter D_(m1) is greater than the long axis MVA1of the native mitral valve (shown in FIG. 5C) when the device 100 is inthe expanded configuration 102 (FIG. 17A). In another embodiment, themajor perimeter diameter D_(m1) is less than the long axis MVA1 when thedevice 100 is in the expanded configuration 102. In such embodiments,the device 100 can be configured to have a major perimeter diameterD_(m1) that is greater than the long axis MVA1 when the device is in thedeployed configuration (e.g., when engaging the tissue on or under thenative annulus, see FIG. 16E). Further, the minor perimeter diameterD_(m2) can be greater than the short axis MVA2 of the native mitralvalve (shown in FIG. 5C) when the device 100 is in the expandedconfiguration 102 (FIG. 17A), or alternatively in the deployedconfiguration (FIG. 16E). In one embodiment, the major perimeterdiameter D_(m1) and/or minor perimeter diameter D_(m2) can beapproximately 2 mm to approximately 22 mm, or in another embodiment,approximately 8 mm to approximately 15 mm greater than the long axisMVA1 and/or the short axis MVA2, respectively, of the native mitralvalve. In some embodiments, the major perimeter diameter can beapproximately 45 mm to about 60 mm and the minor perimeter diameter canbe approximately 40 mm to about 55 mm.

Again referring to FIG. 16C, the upstream portion 212 of the anchoringmember 210 can be radially separated from the valve support 120 by a gap257. In one embodiment, the gap 257 is greater on an anterior leafletfacing side of the device 100 (e.g., along the third region 255) than ona posterior leaflet-facing side of the device 100 (e.g., along thefourth region 256).

Referring back to FIGS. 16A and 16C, the valve support 120 can beoriented along the first longitudinal axis 101 and the anchoring member210 can be oriented along the second longitudinal axis 201. The secondlongitudinal axis 201 can be off-set from the first longitudinal axis101. “Off-set” can refer to an arrangement where the axes 101, 201 areparallel but separated such that the gap 257 can vary around thecircumference 250 (FIG. 16C). FIG. 16D shows another embodiment in which“off-set” can refer to an arrangement wherein the second axis 201 can beangled from the first axis 101 (e.g., the first and second 101, 201 axesare non-collinear or non-parallel) such that the anchoring member 210 isgenerally tilted with respect to the valve support 120. In oneembodiment, the second longitudinal axis 201 is disposed at a tilt angleA_(TL) between 15° and 45° relative to the first longitudinal axis 101.

In additional embodiments, and as shown in more detail in FIG. 18, thefirst and second regions 253 and 254 of the upstream perimeter 213 canextend further from the longitudinal axis 201 than the third 255 andfourth regions 256. For example, the anchoring member 210 can have agenerally conical body (shown in dotted lines) and have upstream rimextensions 258 in the first and second regions 253 and 254. In someembodiments, the third region 255 of the upstream perimeter 213 canextend further from the longitudinal axis 201 than the fourth region256. In some arrangements, the third region 255 can have a size andshape that allows the anchoring member 210 to engage the inward facingsurface of the anterior leaflet without substantially obstructing theleft ventricular outflow tract (LVOT).

Referring to FIGS. 17A-17C together, the valve support 120 can beoriented along the longitudinal axis 101, and the upstream portion 212of the anchoring member 210 can flare outward from the longitudinal axis101 by a taper angle A_(T). In embodiments where the ribs 214 aregenerally curved outward from the downstream portion 211 to the upstreamportion 212 (rather than linear), the taper angle A_(T) can continuouslychange between the downstream portion and the upstream portion. In someembodiments, the taper angle A_(T) can be the same around thecircumference 250 of the upstream portion 212 of the anchoring member210; however, in other embodiments, the taper angle A_(T) can varyaround the circumference 250. For example, the anchoring member 210 canhave a first taper angle A_(T1) at the first and second regions 253 and254 (FIG. 17B) which can be configured to align with the anterolateralcommissure AC and posteromedial commissure PC (see FIG. 5C),respectively. The anchoring member 210 can further have a second taperangle A_(T2) at the third region 255 which can be configured to alignwith the anterior leaflet, and a third taper angle A_(T3) at the fourthregion 256 which can be configured to align with the posterior leaflet(FIG. 17C). In one embodiment, the taper angle can be approximately 30°to about 75°, and in another embodiment, between approximately 40° andabout 60°.

One important aspect of having asymmetric rib lengths for the anchoringmembers is that different lengths might mean that one side or segment ofthe anchoring member is exposed from the delivery system before theothers, allowing the physician deploying the device to optimize theorientation of the device prior to full deployment.

These variations in shaping of the anchoring member can serve severalfunctions. One is to ensure a better fit with the native valve annulus.Another is to optimize the bending load on each rib and section of theanchoring member in the deployed position, in part to minimize long-termfatigue stresses on the ribs. A third reason is to ensure that theanchoring member, when deployed in the mitral annulus, does not impartasymmetric forces on the valve support member. A fifth is to reduce theforce of the deployed device against the anterior leaflet, so theleaflet isn't excessively displaced towards the aortic valve. By makingsure that the middle of the anterior leaflet is less radially expanded,the radius of curvature of the circumference of the anchoring memberwill be higher in that area, and per Laplace's law, the radial force ofthat area will be lower.

FIG. 16E is a schematic top view of a native mitral valve in the heartviewed from the left atrium and showing the prosthetic treatment device100 of FIG. 16A-16C implanted at the native mitral valve MV inaccordance with an embodiment of the present technology. Once deployed,and as illustrated in FIG. 16E, at least a portion of the upstream endsof the ribs 214 (shown in FIGS. 16B-16C) engage a subannular surface ofthe native valve (e.g., mitral valve). As described in more detailbelow, certain embodiments of ribs 114 or 214 are configured topenetrate subannular tissue to anchor and further stabilize the devices100.

Although the anchoring member 210 is deformable in response todistorting forces exerted by the native anatomy, the valve support 120can have sufficient rigidity to maintain a circular or other originalcross-sectional shape, thus ensuring proper functioning of theprosthetic valve leaflets 132 when opening and closing. Such mechanicalisolation from the anchoring member 210 may be achieved by the valvesupport 120 having sufficient rigidity to resist deformation whileanchoring member 210 is deformed, and by selecting a location and meansfor coupling the valve support 120 to the anchoring member 210 so as tomitigate the transmission of forces through the anchoring member 210 tothe valve support 120 or the prosthetic valve 130 contained therein. Forexample, the valve support 120 may be coupled to the anchoring member210 only at the downstream end 123 of the valve support 120, which isseparated from the upstream end 121 where the anchoring member 210engages the annulus. On the upstream end 121, the valve support 120 maybe completely unconnected to and spaced radially apart from theanchoring member 210 by the gap 257 to allow deformation of theanchoring member 210 without impacting the shape of valve support 120(see FIGS. 16A-16C where the prosthetic valve 130 is located). Thus,forces exerted on the anchoring member 210 by the annulus can beabsorbed by the flexible ribs 214 of the anchoring member 210 tomitigate transmission of such forces to the downstream end 123 of valvesupport 120.

In some embodiments, it may be desirable to limit a distance the device100 extends downstream of the annulus into the left ventricle (e.g., tolimit obstruction of the left ventricle outflow tract (LVOT)).Accordingly, some embodiments of the device 100 can include anchoringmembers 210 having a relatively low overall elevation (e.g., elevationsE₁, E₂ and E₃, FIGS. 17B-17C), such that the anchoring member 210 doesnot extend into or obstruct the LVOT. As shown in the side view of FIG.16B, for example, the anchoring member 110 can have a low overallelevation E_(L) (e.g., the distance between the upstream perimeter 213and the downstream perimeter 215 of the anchoring member 210) withrespect to a height H_(V) of the valve support 120. In such embodiments,the upstream perimeter 213 of the anchoring member 110 may be justbelow, adjacent to, or positioned within the annulus of the nativemitral valve while the downstream perimeter 215 of the anchoring member210 is configured to extend minimally into the left ventricle below thenative mitral valve annulus when the device 100 is implanted. In somearrangements, the valve support 120 can be coupled to anchoring member210 so as to also minimize protrusion into the left ventricle, and insome embodiments, may extend upwardly through the plane of the nativeannulus into the left atrium.

Additional Components and Features Suitable for Use with the ProstheticHeart Valve Devices

Additional components and features that are suitable for use with theprosthetic heart valve devices (e.g., devices 100 described above) aredescribed herein. It will be recognized by one of ordinary skill in theart that while certain components and features are described withrespect to a particular device (e.g., device 100), the components andfeatures can also be suitable for use with or incorporated with otherdevices as described further herein.

As discussed above with respect to FIG. 10A, some embodiments of theprosthetic heart valve device 100 can include a sealing member 140 thatextends around portions of the anchoring member 110 and/or the valvesupport 120. For example, the embodiment illustrated in FIG. 10A has asealing member 140 around the inner wall 141 of the anchoring member 110and around an exterior surface 127 of the valve support 120 to preventparavalvular leaks both between the device 100 and the anatomy but alsothrough components of the device 100.

FIGS. 19A-19C are isometric, side and top views, respectively, of aprosthetic heart valve device 100 having a sealing member 140 inaccordance with a further embodiment of the present technology.Referring to FIGS. 19A-19C together, the device 100 includes a sealingmember 140, such as a skirt 144. The skirt 144 can be disposed on theouter wall 142 or disposed on the inner wall 141 and at least partiallyover the upstream perimeter 113 of the anchoring member 110.Accordingly, the skirt 144 can be fixed and/or coupled to any surface ofthe anchoring member 110. The skirt 144 can also overlay an interiorsurface 126 (shown in FIG. 19A) and/or exterior surface 127 of the valvesupport 120. Variations of the skirt 144 and/or other sealing members140 can be configured to (1) create a blood flow-inhibiting seal betweenthe anchoring member 110 and the native tissue, (2) block blood flowthrough the walls 141, 142 of the anchoring member 110 and/or throughthe surfaces 126, 127 of the valve support 120, and (3) block blood flowthrough the space between the valve support 120 and the anchoring member110. In some embodiments, the sealing member 140 can be configured topromote in-growth of adjacent tissue. The sealing member 140 can help toseal between the anchoring member 110 and the valve support 120, as wellas between the device 100 and the surrounding anatomy such that bloodflow is restricted to flowing through the prosthetic valve 130 from theleft atrium to the left ventricle. Additionally, the sealing member 140can provide circumferential support for the anchoring member 110 when inthe expanded configuration 102 (FIGS. 10A, 16A and 19A) or deployedconfiguration 104 (FIGS. 10B and 16B). In some embodiments, the sealingmember 140 may further serve to attach the anchoring member 110 to thevalve support 120. For example, the skirt 144 can be coupled to theinner wall 141 of the anchoring member 110 and integrally formed with orotherwise attached to the sealing member 140 that is coupled to thevalve support 120. In other embodiments, the sealing member 140 can beused to couple the valve support 120 to the prosthetic valve 130 housedin the interior of the valve support 120. Sealing members 140, such asskirts 144, can be coupled to the anchoring member 110 and/or valvesupport 120 with sutures, rivets or other known mechanical fasteners. Inother embodiments, adhesives, glues and other bonding materials can beused to couple the sealing members to components of the device 100.

FIG. 20A is an isometric view of a prosthetic heart valve device 100without a sealing member 140, and FIGS. 20B-20E are isometric views ofprosthetic heart valve devices 100 having sealing members 140 inaccordance with additional embodiments of the present technology. Forexample, FIGS. 20B-20C show embodiments of the device 100 in which thesealing member 140 is a sleeve 146. The sleeve 146 can include animpermeable sealing material that is cylindrical and configured to fitwithin or over various frame or skeleton structures of the device 100 asfurther described below. In FIG. 20B the sleeve 146 is on the exteriorsurface 127 of the valve support 120, whereas in FIG. 20C, the sleeve146 is also disposed on the inner wall 141 of the anchoring member 110and on the exterior surface 127 of the valve support 120. FIG. 20Dillustrates an embodiment of the device 100 in which the sleeve 146 isdisposed on the outer wall 142 of the anchoring member 110 and on theexterior surface 127 of the valve support 120. Referring to FIG. 20E,the device 100 can also incorporate the sleeve 146 on both the outerwall 142 and inner wall 141 of the anchoring member 110 as well as onthe exterior surface 127 of the valve support 120.

One of ordinary skill in the art will recognize that the sealing members140, such as the skirts 144 and sleeves 146 shown in FIGS. 19A-20E, canfully cover the walls 141, 142 or surfaces 126,127, or in otherembodiments, at least partially cover the walls 141, 142, and/or thesurfaces 126, 127 of the anchoring member 110 and the valve support 120,respectively. Any combination of sealing members 140 is contemplated.Additionally, the sealing member 140 can comprise a single continuoussheet of fluid impervious material (e.g., for covering the inner surface141 of the anchoring member 110 and the exterior surface 127 of thevalve support 120), which could create a seal between the anchoringmember 110 and the valve support 120. In various embodiments, thesealing member 140, such as the skirt 144 or sleeve 146, can comprise afabric or other flexible and biocompatible material such as Dacron®,ePTFE, bovine pericardium, or other suitable flexible material tointegrate with tissue and minimize paravalvular leaks. In otherembodiments, the sealing member 140 can include a polymer, thermoplasticpolymer, polyester, Gore-tex®, a synthetic fiber, a natural fiber orpolyethylene terephthalate (PET). The valve 130 may also be attached tothe sealing member 140 or integrally formed with the sealing member 140.

In a further embodiment, shown in FIGS. 21A-21F, the valve support 120may comprise a tubular member 148 of fabric, polymer, or pericardiumwith little or no metallic or other structural support. Referring toFIGS. 21A-21B, the tubular member 148 may be a thicker and more rigidportion of a sleeve 146 which is capable of retaining its shape and hassufficient strength to resist radial and axially tensile forces duringsystole, and axial compressive forces during diastole. The leaflets 132of the prosthetic valve 130 may be integrally formed with, sewn orotherwise attached to the tubular member 148. In one embodiment, thetubular member 148 can be integrally formed with an outer portion 146Aof the sleeve 146 that extends around the anchoring member 110 (shown inFIG. 21A), or in another embodiment, the tubular member 148 can be aseparate and/or thicker member which is sewn, bonded, or otherwisefastened to the sleeve 146 in a blood-tight manner. The tubular member148 can optionally include reinforcing members to give it greaterstrength and to help it retain a desirable shape suitable for operatingthe valve 130. For example, a series of relatively stiff longitudinalstruts 190 of metal or polymer can be coupled to or embedded within thewalls of tubular member 148 (FIG. 21C), and/or a wire coil 192 mayextend around or be embedded within walls of the tubular member 148(FIG. 21D). In a further embodiment, a series of tethers 194 can becoupled between the outer portion 146A of the sleeve 146 and tubularmember 148 (FIG. 21E). In one arrangement, the tethers 194 can extend ata downstream angle from the upstream portion 112 of the anchoring member110 so as to inhibit collapse or structural compromise of the tubularmember 148 during atrial systole. In yet another embodiment, a pluralityof vertical septa 196 may be interconnected between the anchoring member110 (and/or a sealing member 140 coupled to the inner wall 141 of theanchoring member 110) and the tubular member 148 (FIG. 21F). Theplurality of vertical septa 196 coupled between the anchoring member 110and the valve support 120 can be a flexible fabric or polymer, and insome embodiments, can be the same material used for the sleeve 146. Thesepta 196, which can be collapsed with the anchoring member 110 to a lowprofile delivery configuration (not shown) can also constrain theoutward deflection of the ribs 114 when the device 100 is in theexpanded configuration 102.

As described herein, the anchoring member 110 can be a structure orcomponent separate from the valve support 120. In one embodiment, theanchoring member 110 can be coupled to the valve support 120 at, forexample, a downstream end 123 of the valve support 120, while theupstream portion of the anchoring member 110 can remain uncoupled to thevalve support 120 and/or other otherwise be mechanically isolated fromthe valve support 120. The anchoring member 110 can be coupled to thevalve support 120 using a variety of mechanisms, including flexible, ornon-rigid, coupling mechanisms. FIGS. 22A-22G and 221-22K are enlargedside views of various mechanisms of coupling the valve support 120 tothe anchoring member 110 that allow relative movement between thedownstream portions or the anchoring member 110 and the valve support120 or otherwise provide mechanical isolation of the valve support 120from the anchoring member 110 in accordance with additional embodimentsof the present technology.

FIGS. 22A-22B illustrate a downstream end 326 of a rib 114 of theanchoring member 110 coupled to a post 122 of the valve support 120. Ina first embodiment, the rib 114 can be coupled to the post 122 by asuture, wire or other suitable filament 310 which is wrapped around theadjacent elements and tied (FIG. 22B). In some embodiments, either orboth the rib 114 and the post 122 may have a feature to which thefilament 310 may be secured, such as a through-hole 312 (FIG. 22C), aloop or eyelet 314 (FIG. 22D), or a groove 316 configured to retain thefilament 310 therein and inhibit sliding along the rib 114 or post 122.

In another embodiment shown in FIG. 22F, the rib 114 can be coupled tothe post 122 by a rivet, screw, pin, or other fastener 318 which passesthrough aligned holes 319 in the rib 114 and the post 122.Alternatively, and as shown in FIGS. 22G-22H, the post 122 may have acavity 320 in its outer wall configured to receive a downstream end 326of rib 144, and the two elements 114, 122 can be fastened together by afilament or fastener 322. In this arrangement, a substantial portion ofthe systolic force exerted on the valve support 110 can be translateddirectly to the rib 114 because the downstream end of the rib 114engages the floor of the cavity 320, thereby relieving the suture orfastener 322 from having to resist such force.

In further embodiments shown in FIGS. 221-22J, a downstream end 326 ofthe rib 114 passes through a passage 324 formed through the post 122.The downstream end 326 is then secured to post 122 by a fastener 328 ora filament like those described above. Additionally, because the rib 114is held within the passage 324, the systolic loads exerted on the valvesupport 120 can be translated directly to the ribs 114 rather than tothe fastener 328. In yet another embodiment shown in FIG. 22K, adownstream end 330 of the post 122 is formed radially outward in a hookor J-shape, forming a channel 332 in which a downstream end 326 of therib 114 can be received. The ends 330, 326 of the two elements may besecured by a fastener 334 passing through holes 319 in the rib 114 andthe post 122. Systolic loads applied to the post 122 can be translateddirectly to the rib 114 via channel 332, relieving fastener 334 frombearing a substantial portion of the load.

FIGS. 23A-23B illustrate further embodiments of mechanisms suitable forcoupling the anchoring member 110 to the valve support 120. In theembodiments shown in FIGS. 23A-23B, circumferential connectors 116 ofthe anchoring member 110 are coupled to the struts 124 of the valvesupport 120. For example, in FIG. 23A, the connectors 116 are formed soas to have an hourglass-shaped portion 336 forming a waist 338 and anenlarged connector head 340 forming a connector cell 341. Struts 124similarly have an enlarged strut head 346 forming a strut cell 347. Thehourglass portion 336 of the connector 116 can be configured to passthrough the strut cell 347 such that the strut head 346 extends aroundthe waist 338 of the connector 116. The connector head 340 can besufficiently large that it is prevented from being released from thestrut cell 347. Further, due to the diverging angles of connectorsegments 116A, 116B, the strut head 346 can be prevented from slidingupward relative to the connector head 340. In such arrangements,systolic loads exerted in the upward direction on the valve support 120can be translated through the struts 124 to the connectors 116, which inturn translate these forces to the ribs 114 which are driven into thenative anatomy to anchor the device 100 in place.

In FIG. 23B, the connectors 116 can be formed so as to have a loopportion 348 extending downwardly which is nested in a concave portion350 formed in the strut 124. The loop portion 348 can be fastened to theconcave portion 350 in various ways, e.g. by a suture 352 wrapped aroundeach member 348, 350. In this arrangement, systolic loads applied tovalve support 120 in the upstream direction can be transferred throughthe concave portion 350 to loop portions 348 of the anchoring member110.

In other embodiments, the anchoring member 110, or selected componentsthereof, can be integrally formed with the valve support 120. As shownin FIG. 24A, the ribs 114 of the anchoring member 110 can be integrallyformed with posts 122 of the valve support 120 with a U-shaped bridgemember 356 interconnecting each rib 114 to respectively aligned posts122. The ribs 114 may be circumferentially interconnected by expandableconnectors 116 formed integrally therewith. Alternatively, in theembodiment shown in FIG. 24A, a plurality of separate bands or wires 358extend around the circumference 150 of the anchoring member 110 and areeach slideably coupled to the ribs 114, e.g. by extending through a hole360 formed in each individual rib 114. The flexible bands or wires 358permit ribs 114 to be collapsed inwardly to a low-profile deliveryconfiguration (not shown), while limiting the outward deflection of theribs 114 when in the expanded configuration 102. Alternatively, a tether361 of wire or suture may be coupled between the individual ribs 114 andthe posts 122 (shown in FIG. 24B) to limit the outward deflection of theribs 114 when in the expanded configuration 102.

In further embodiments, a sleeve 146 may be secured to the ribs 114 in amanner which limits the outward deflection of the ribs 114 when thedevice 100 is in the expanded configuration (shown in FIG. 24C). Thesleeve 146 may, for example, extend around the outer side of each rib114 as shown in FIG. 24C to constrain it from expanding outwardly beyonda predetermined limit. Optionally, the sleeve 146 may further include ahorizontal septum 359 extending between an inner portion 146B of thesleeve 146 that extends around the valve support 120 and an outerportion 146A of the sleeve 146 that extends around the anchoring member110. The horizontal septum 359 can more rigidly constrain the outwardflexion of the ribs 114. In some embodiments, the septum 359 can alsoseal the annular cavity 163 formed by the septum 359 between the innerportion 146B and the outer portion 146A to limit blood flow into thiscavity 163 and minimizing clot formation therein. Alternatively,openings (not shown) may be formed in the sleeve 146 downstream of theseptum 359 which can permit blood to flow into the enclosed cavity 163to form a region of clot, thereby limiting the deflection of the ribs114 and making the device more rigid and securely anchored. The septum359, which can be a flexible fabric, polymeric, or pericardial material,can be located at the upstream end of the device 100 as shown, or at alocation spaced further downstream from the upstream end 121 of thevalve support 120. In a further embodiment shown in FIG. 24D, eachindividual rib 114 can be constrained within a passage 364 formed in thesleeve 146 by suturing or bonding two layers of sleeve fabric together.In the expanded configuration 102, the movement of the ribs 114 can belimited relative to the sleeve 146.

FIG. 25A is a partial cross-sectional view of a prosthetic heart valvedevice 100 having an anchoring member 110 and a valve support 120, andFIG. 25B is an enlarged view of the designated box shown in FIG. 25A inaccordance with an embodiment of the present technology. As shown inFIGS. 25A and 25B, there can be a gap 108 between the valve support 120and lower portion 111 of the anchoring member 110. If the gap 108exists, the gap 108 can be protected by a sleeve 146 to prevent bloodfrom leaking between the anchoring member 110 and the valve support 120in either an upstream or downstream direction.

FIGS. 26A-26D are schematic cross-sectional views of prosthetic heartvalve devices 100 having atrial retainers 410 and implanted at a nativemitral valve MV in accordance with various embodiments of the presenttechnology. FIGS. 26A-26C show several embodiments of the device 100 inwhich the device 100 includes an atrial retainer 410 configured toengage a supra-annular surface of the annulus AN or other tissue withinthe left atrium to assist the native leaflets in preventing downstreammigration of the device 100 into the left ventricle. In thesearrangements, the annulus AN can be sandwiched between a topcircumference 150 of the anchoring member 110 and a bottom surface ofthe atrial retainer 410.

As shown in FIG. 26A, one embodiment of the device 100 can include theatrial retainer 410 coupled to or integrally formed with the inner valvesupport 120. The atrial retainer 410 can extend upstream through theannulus AN and into a supra-annular space within the atrium and engagethe supra-annular surface or other atrial tissue with an outwardlyextending flange 420. In another embodiment shown in FIG. 26B, theatrial retainer 410 can comprise a plurality of fingers 412 which may beformed integrally with or otherwise coupled to the valve support 120(e.g. comprising upward extensions of posts 122 or upward extensions ofthe anchoring member 110). The fingers 212 can be generally uncovered orexposed within the left atrium as illustrated in FIG. 26B; however, inanother embodiment, the fingers 412 can be covered with a sealing member(not shown) or other covering of fabric, polymeric sheet, or pericardialtissue extending around the outside or inside surfaces of the fingers412 to form a conical shape to help seal the device 100 with the nativetissue on the atrial side of the annulus AN and to help funnel bloodinto the prosthetic valve 130 (FIG. 10A). The fingers 412 may alsoinclude circumferential struts (not shown) interconnecting the fingers412 to limit lateral deflection and enhance the stiffness of thefingers. The fingers 412 can include a resilient shape memory material(e.g., Nitinol) such that the fingers can be straightened and deflectedinwardly for delivery and be released to an unbiased, radiallyprojecting outward position in the expanded configuration 102 as shown.For example, the fingers 412 can have finger tips 414 biased outwardlyand, in some arrangements, in the downstream direction in the expandedconfiguration 102. During delivery to a desired position within thenative mitral valve MV, the device 100 can be unsheathed in the distalor downstream direction (discussed in more detail below), such that thefingers 412 are first released to engage the atrial side of the valveannulus AN. This indexes the position of the device 100 relative to thenative valve to ensure that the anchoring member 110 is positioned onthe ventricular side of the native annulus AN but not overextended intothe ventricle when it is unsheathed and expanded.

The atrial retainer 410 may alternatively be an extension of theanchoring member 110. In one embodiment shown in FIG. 26C, the atrialretainer 410 can include a plurality of atrial loops 416, which,although depicted in a more vertical plane, may alternatively lie in aplane more parallel to the plane of the native annulus AN, and whichextend upstream through the annulus AN, then extend radially outwardlyto engage a supra-annular surface. The loops 416, which may compriseextensions of one or more ribs 114 of the anchoring member 110, caninclude a resilient shape-memory metal (e.g., Nitinol) or other materialthat may be compressed into a low profile shape for delivery thenreleased to expand to the radially-extended configuration shown in FIG.26C. Similar to the device 100 of FIG. 26C, FIG. 26D is also across-sectional view of a prosthetic heart valve device 100 thatincludes an atrial retainer 410 formed by an extension of the anchoringmember 110. As shown in FIG. 26D, the atrial retainer 410 can include acylindrical portion 418 which extends upwardly from the anchoring member110 through the native annulus AN, with a flange 420 at the proximalregion which extends over the atrial side of the native annulus AN toengage the supra-annular surface. The flange 420 can include a resilientshape memory material (e.g., Nitinol) that can be collapsed for deliveryand expand when deployed at the native mitral valve MV. The cylindricalportion 418 and flange 420 may be integrally formed with the anchoringmember 110, e.g. comprised of extensions of the ribs 114, or in anotherembodiment, can be coupled to one or more portions of the anchoringmember 110 and/or the valve support 120.

In other embodiments, the prosthetic heart valve device 100 can includeatrial extending features that assist in retaining the device 100 in adesired location within the native mitral valve, but do notsubstantially engage atrial or supra-annular tissue. For example, FIG.27 is a side view of an anchoring member 110 having a vertical portion422 at the upstream end 424 for engaging the annulus AN in accordancewith another embodiment of the present technology. The anchoring member110 can include the lower portion 111 and the upper flared portion 112which is positionable in a subannular location between the leaflets LFand downstream of the annulus AN. The upstream portion 112 can beexpandable to a dimension that is larger than a corresponding dimensionof the subannular tissue and/or inward facing leaflets LF. The verticalportion 422 can be fitted within the annulus orifice so as to engage theannulus AN around an entire upstream circumference 150 of the anchoringmember 110. The vertical portion 422 can be expandable to a dimensionthat is larger than a corresponding dimension of the annulus AN suchthat radial expansion of the vertical portion 422 presses outwardlyagainst the native tissue to assist retaining the device in the desiredlocation with the native mitral valve. Optionally, the anchoring member110 can also include a plurality of tissue engaging elements 170, suchas spikes. In one embodiment, the spikes (shown here as tissue engagingelements 170) can be distributed around the circumference 150 of theupper portion 112 of the anchoring member 110 and oriented such that thespikes can penetrate tissue in a subannular location and can beconfigured to help the anchoring member 110 resist movement in either anupstream or downstream direction.

Prosthetic Heart Valve Devices Having Stabilizing Members

FIG. 28 illustrates one embodiment of the prosthetic heart valve device100 in an expanded configuration 102 that further comprises one or morestabilizing members 501 to help stabilize the device 100 at the nativevalve site and, in some embodiments, prevent tilting or lateralmigration, or to inhibit upstream or downstream migration of the device100. In some embodiments, the stabilizing members 501 may comprise oneor more arms 510 extending from a lower or downstream portion 111 of theanchoring member 110. The arms 510 are configured to engage the nativetissue, e.g. the valve leaflets, subannular tissue, or ventricular wall,either inside or outside the native leaflets, depending on theconfiguration.

FIG. 29 is an enlarged schematic, side view of a prosthetic heart valvedevice having an extended arm in accordance with an embodiment of thepresent technology. As shown in FIG. 29, an individual arm 510 maycomprise an arm body 512, an arm extension 514, and an arm tip 516. Thearm body 512 has an arm body length L₁ and may connect to a post 511 ata first joint 508. The post 511 can be a valve support post 122, ananchoring member rib 114, and/or another feature of the device 100(e.g., strut 124 or connector 116). A first arm angle A_(A1) is formedby the intersection of the axes of post 511 and the arm body 512; thefirst arm angle A_(A1) selected such that the arm 512 is positionable sothat the tip 516 can engage the native tissue at a desired location,e.g. the subannular tissue or ventricular wall behind the nativeleaflets. FIGS. 30A-30C are enlarged partial side views of a prostheticheart valve device 100 having arms 510 coupled to the device at variousangles with respect to a longitudinal axis 101 of the device inaccordance with further embodiments of the present technology. In oneembodiment, the first arm angle A_(A1) can be about 10° to about 45°. Inother embodiments, the first arm angle A_(A1) can be an obtuse angle(FIG. 30A), generally perpendicular or approximately a 90° angle (FIG.30B), or an acute angle (FIG. 30C).

Referring back to FIG. 29, the arm body 512 can connect to the armextension 514 at a distal end of the arm body 512. The arm extension 514can have an arm extension length L₂ which can be selected or optimizedfor penetrating a desired distance into the native tissue, such as about0.5-2 mm. The arm extension 514 can extend from the arm body 212 atsecond arm angle A_(A2). The second arm angle A_(A2) can be formed bythe intersection between the arm extension 514 and arm body 512 and beselected to provide the desired angle of engagement with the nativetissue, such as about 100° to about 135°. In other embodiments, the armextension 514 may be parallel or collinear with the arm body 512 (notshown), or may be eliminated entirely. The arm extension 514 terminatesat the arm tip 516. In embodiments without an arm extension 514, the armtip 516 can be the most distal portion of the arm body 512 (not shown).

The arm 510 may have an arm height H_(A1) extending from the first joint508 to the most distal reaching point of the arm, which could be the armtip 516 (shown in FIG. 29) along an axis parallel to the longitudinalaxis 101 of the device 100. The arm height H_(A1) can be selected oroptimized such that the arm tip 516 engages a desired location in thesubannular anatomy when the device 100 is in a desired longitudinalposition relative to the native mitral valve (e.g., when the anchoringmember 110 is in engagement with the subannular tissue). The arm heightH_(A1) will depend upon of the overall height of the anchoring member110 and/or valve support 120 as well as the location of the joint 508.FIGS. 31A-31C are enlarged, partial side views of prosthetic heart valvedevices having arms 510 of various lengths (L₁+L₂), and accordinglyhaving variable heights H_(A1). As shown, the arm height H_(A1) may begreater than the overall height H_(D1) of the anchoring member 110(represented by rib 114) or valve support (FIG. 31A), be intermediatebetween the respective heights H_(D1), H_(V1) of the anchoring member110 (represented by rib 114) and the valve support 120 (represented bypost 122) (FIG. 31B), or be less than the overall height H_(D1) of boththe anchoring member 110 (represented by rib 114) and the valve support120 (FIG. 31C).

Additional details and embodiments regarding the structure andattachment of arms or other stabilizing members suitable for use withthe device 100 can be found in International PCT Patent Application No.PCT/US2012/043636, entitled “PROSTHETIC HEART VALVE DEVICES ANDASSOCIATED SYSTEMS AND METHODS,” filed Jun. 21, 2012, the entirecontents of which are incorporated herein by reference.

FIGS. 32A, 32B, 32C, and 32D are cross-sectional views of a heart withan implanted prosthetic heart valve device 100 having arms 510 adisposed on an inward-facing surface of the leaflets LF, and FIGS.32A-1, 32B-1, 32C-1 and 32D-1 are enlarged views of the arms 510 aengaging the inward-facing surface of the leaflets as shown in FIGS.32A, 32B, 32C and 32D, respectively. The embodiments of prosthetic heartvalve devices 100 illustrated in FIGS. 32A-32D-1 have arms 510 aconfigured to expand to a position radially inside the leaflets LF,radially outside the leaflets LF, or a combination of inside and outsidethe leaflets LF. For example, FIGS. 32A and 32A-1, show arms 510 aexpanding and engaging an inward surface of the leaflets LF and show thearms 510 a partially piercing the leaflets LF. In another exampleillustrated in FIGS. 32B and 32B-1, the arms 510 a may fully penetratethe leaflets LF. In a further example, the device 100 can incorporatearms 510 a that 1) completely penetrate the leaflets LF and 2) partiallypierce subannular tissue (FIGS. 32C and 32C-1). Referring to FIGS. 32Dand 32D-1, the device 100 can be configured to incorporate arms 510 athat fully penetrate both the leaflets LF and the annular tissue of themitral valve MV.

FIGS. 33A-33C are schematic views illustrating various embodiments oftissue engaging elements 170 for use with prosthetic heart valve devices100 in accordance with the present technology. Tissue engaging elements170 can include any feature that engaged tissue in an atraumatic manner,such as a blunt element, or which partially pierces or fully penetratescardiac tissue, such as a barb or spike. As used herein, “tissueengaging” refers to an element 170 which exerts a force on the tissue Tbut does not necessarily pierce the tissue T, such as being atraumaticto the tissue T, as shown in FIG. 33A. As used herein, “partiallypiercing” refers to a tissue engaging feature 170 which at leastpartially penetrates the tissue T but does not break through an oppositesurface S, as shown in FIG. 33B. As used herein, “fully piercing” refersto a tissue engaging feature 170 which can both enter and exit thetissue T, as shown in FIG. 33C. “Piercing” alone may refer to eitherpartial or full piercing. Tissue engaging elements 170 may take the formof spikes, barbs, or any structure known in art capable of piercingcardiac tissue, or alternatively, any blunt or atraumatic featureconfigured to apply pressure on the cardiac tissue without piercing thetissue. Further details on positioning of such elements is describedherein.

FIGS. 34A, 34B and 34C are cross-sectional views of a heart with animplanted prosthetic heart valve device 100 having arms 510 a withtissue engaging elements 170 disposed on an inward-facing surface of theleaflets LF, and FIGS. 34A-1, 34B-1 and 34C-1 are enlarged views of thearms 510 a engaging the inward-facing surface of the leaflets LF asshown in FIGS. 34A, 34B and 34C, respectively. As illustrated in FIGS.34A-34C-1, tissue engaging elements 170 can be incorporated on andextend from the arms 510 a in either a downstream direction (FIGS. 34Aand 34A-1), upstream direction (FIGS. 34B and 34B-1), or in both thedownstream and upstream directions (FIGS. 34C and 34C-1). In otherembodiments, the tissue engaging elements 170 can be incorporated on andextend from the components of the anchoring member 110 and/or the valvesupport 120 in either or both the upstream and downstream directions.

FIGS. 35A-35C are side views showing prosthetic heart valve devices 100implanted at a mitral valve MV (illustrated in cross-section) in adeployed configuration 104, wherein the devices have arms 510 b forengaging an outward-facing surface of the native leaflets LF inaccordance with various embodiments of the present technology. FIG. 35Ashows an embodiment of the device 100 that includes arms 510 bconfigured to extend from the downstream end of the device 100 (e.g.,the ventricular end of a device implanted at a native mitral valvedownstream of the leaflets) to reach behind the leaflets LF such thatthe leaflets LF are effectively sandwiched between the arms 510 b andthe outer wall 142 of the anchoring member 110. In another embodiment,and as shown in FIG. 35B, the arms 510 b may cause leaflets LF to foldupon themselves in the space between the arms 510 b and the outer wall142 of the anchoring member 110. In a further embodiment illustrated inFIG. 35C, the arms 510 b can also include the tissue engaging elements170. FIG. 35C-1 is an enlarged view of the arm 510 b having tissueengaging elements 170 for engaging the outward-facing surface of theleaflets LF as shown in FIG. 35C. As shown in FIG. 35C-1, the arms 510 bconfigured to engage an outside-facing surface of the native leaflets LFmay include tissue engaging elements 170 on an inside surface of thearms 510 b such that they are oriented toward the leaflet tissue.

In accordance with another embodiment of the present technology, FIG.36A is a side view showing a prosthetic heart valve device 100 implantedat a mitral valve MV (illustrated in cross-section). The device shown inFIG. 36A has arms 510 b for engaging an outward-facing surface of thenative leaflets LF and arms 510 a for engaging an inward-facing surfaceof the native leaflets LF. Inside/outside arms 510 a, 510 b may furthercomprise tissue engaging elements 170 on a radially inside surface orradially outside surface of the arms 510 a, 510 b, respectively, forengaging or piercing the leaflet tissue. The arrangement ofinside/outside arms 510 a, 510 b around a circumference of the device100 can alternate in a pre-designed pattern. For example, inside arms510 a can alternate with outside arms 510 b as shown in FIG. 36B, oralternatively, arms 510 a, 510 b may extend radially outward and/orradially inward randomly or at irregular intervals, depending onplacement of the device 100 and with respect to alignment with thenative posterior and anterior leaflets.

FIGS. 37A-37D are enlarged side views of additional embodiments of arms510 suitable for use with a prosthetic heart valve device 100 inaccordance with the present technology. For example, in FIGS. 37A-37D,the arms 510 can have a similar overall profile as a profile of theanchoring member 110. The anchoring member 110 can include ribs havingvarying shapes, sizes and/or outwardly or inwardly oriented rib segments85 for forming the overall anchoring member profile. Accordingly, thearms 510 can also have varying shapes, sizes and/or outwardly orinwardly oriented arm segments that mimic the anchoring member 110profile. In some arrangements, the embodiments shown in FIGS. 37A-37Dare configured to clamp leaflets LF and/or the annulus AN tissue betweenthe arms 510 and the ribs 114 so as to conform the leaflet tissue to theshape of the anchoring device 110 for enhanced sealing and anchoring ofthe device. For example, FIG. 37A illustrates one embodiment in whicharm extensions 514 and/or arm bodies 512 may partially mimic the shapeof the ribs 114 and/or rib segments 85, and FIG. 37B illustrates anotherembodiment in which arm extensions 514 and/or arm bodies 512 moreclosely follow the shape of the ribs 114. Embodiments encompassed byFIGS. 37A-37B can apply to outward surface engaging arms 510 b and/orinward surface engaging arms 510 a. Additionally, as shown in FIGS.37A-37B, the arm extensions 514 can extend radially outwardly so as tobe generally parallel with an upstream segment 85A of the rib 114. Thearm extension 514 can be configured to extend partially along the lengthof the rib 114 and/or rib segments 85 (FIGS. 37A and 37C) or fully alongthe length of the rib 114 and/or rib segments 85. In FIG. 37D, the arms510 have second arm extensions 518 connected to an upstream portion ofthe first arm extension 514 and extending outwardly so as to begenerally parallel to a second rib segment 85B and third rib segment85A.

In some embodiments, the prosthetic heart valve device 100 mayincorporate a plurality of arms 510 around a circumference of the device100; however, in other embodiments, the device may include the pluralityof arms in groupings (e.g., first and second groupings so as to engagethe posterior and anterior leaflets, respectively). Additionally, thearms 510 may extend from the anchoring member 110 and/or valve support120 independently of other components including other arms 510, such asshown in FIG. 38A. In other embodiments and as shown in FIG. 38B, thedevice 100 may further include at least one first arm 510 xinterconnected with at least one second arm 510 y by interconnecting armstruts 520. The arm struts 520 can be configured to be circumferentiallyexpandable and may connect all arms 510 (e.g., arm 510 x and 510 y) orone or more groups of arms 510. In some embodiments, the arm struts 520can limit the outward extension of the arms 510 x, 510 y away from thedevice 100.

In accordance with aspects of the present technology, the arms 510 canbe coupled to and/or extend from components of the device 100symmetrically and/or asymmetrically around the circumference 150 of thedevice 100. FIGS. 39A-39D are schematic top views of arm locationpatterns with respect to the ribs 114 of the anchoring member 110 (e.g.,as shown in FIG. 38A). The arms 510 can be interspersed with ribs 114(FIGS. 39A and 39C), in the same radial plane as the ribs 114 of theanchoring member 110 (FIG. 39B), or both interspersed and in plane withthe ribs 114 (FIG. 39D). Further, the arms 510 may be configured toextend outside the expanded outer circumference 150 of the anchoringmember 110 (FIG. 39B), inside the expanded outer circumference 150 ofthe anchoring member 110 (FIG. 39A), extend to the same outercircumference 150 of the anchoring member 110 (FIG. 39C), or acombination of these configurations (FIG. 39D).

In the above-described embodiments, the arms 510 may be configured toengage tissue independently of the deployment of anchoring member 110.For example, delivery catheters suitable for the delivery of theprosthetic heart valve devices 100 may be equipped with separatemechanisms operable to deploy the arms 510 and the anchoring members 110individually or otherwise independently of each other. In this way, theanchoring member 110 may be first released into engagement with thenative tissue so that the position of device 100 may be assessed andadjusted by the operator until the desired final position has beenattained. Following deployment and positioning of the anchoring member110, the arms 510 can be released to engage the tissue. Such deploymentsystems and methods are useful when the arms 510 are equipped withtissue engaging elements 170 which, once deployed, may prohibit anyrepositioning of the device 100. In some embodiments, the anchoringmember 110 will be equipped with atraumatic tissue engagement elements170 which do not penetrate tissue or inhibit device relocation once theanchoring member 110 has been deployed. Accordingly, some embodiments ofthe device 100 may be repositionable even with the anchoring member 110expanded so long as the arms 510 are constrained in an undeployedconfiguration, with the device 100 becoming permanently anchored onlywhen the arms 510 are released.

Alternatively or in addition to tissue engaging elements 170 present onthe arms 510 as described above, tissue engaging elements 170 may bepresent on other components of the device 100. FIGS. 40A-40E are sideviews of prosthetic heart valve devices 100 having tissue engagingelements 170 on varying structures of the device 100 in accordance withadditional embodiments of the present technology. For example, tissueengaging elements 170 can be incorporated on the ribs 114 of theanchoring member 110. FIG. 40A shows tissue engaging elements 170incorporated on the upper rib segment 85A, and FIG. 40B shows the tissueengaging elements 170 incorporated on lower rib segment 85B. FIG. 40Cillustrates an embodiment of the device having the tissue engagingelements 170 along the entire rib 114. The tissue engaging elements 170are shown in FIGS. 40A-40C schematically, but one of ordinary skill inthe art will recognize that the elements can be any of a variety oftissue engaging elements 170 described herein (e.g., atraumatic,partially piercing, fully penetrating, etc.), or in other embodiments, acombination of different types of tissue engaging elements 170.Additionally, the tissue engaging elements 170 are shown oriented in anupstream direction (e.g., to inhibit upstream migration of the device100); however, in other embodiments, the tissue engaging elements 170can be oriented in a downstream direction (e.g., to inhibit downstreammigration of the device 100), or in a combination of downstream andupstream oriented directions. The tissue engaging elements 170 can beincorporated symmetrically around a circumference of the device 100, orin other embodiments, the tissue engaging elements 170 can beincorporated asymmetrically. For example, in some embodiments, thetissue engaging elements 170 can be present on a side of the device 100aligned with the posterior leaflet, but be absent or have a differentarrangement on a side of the device 100 aligned with the anteriorleaflet such that the wall separating the aortic valve from the leftventricle will not be affected by the tissue engaging elements 170.

FIG. 40D illustrates an embodiment of the device 100 having tissueengaging elements 170, such as spikes on an upstream tip 175 of the rib114, wherein the spikes can be configured to fully or partiallypenetrate subannular tissue when the device 100 is deployed on or underthe annulus of the mitral valve. In some embodiments, the tissueengaging elements 170 (e.g., spikes) can include barbs 176 or otherfeatures for retaining the tissue engaging elements 170 (e.g., spikes)in the tissue. In other embodiments, the tissue engaging elements 170(e.g., spikes) can be blunt so as to engage but not penetrate thesubannular tissue. FIGS. 40E-40G are enlarged side views of tissueengaging elements 170 (e.g., spikes) suitable for use on upstream tips175 of the ribs 114. Devices 100 having tissue engaging elements 170 onthe upstream tips 175 can also incorporate features for limiting thedistance of penetration into the tissue. For example, the upstream tip175 can have a hilt 177 formed a short distance, e.g. 1-5 mm, proximalto the tip of each tissue engaging element 170 to limit the distance towhich the tissue engaging element 170 can penetrate the subannulartissue (FIG. 40E). Alternatively, as shown in FIG. 40F, the depthpenetration of the tissue engaging element 170 into the tissue can belimited by positioning connectors 116 a desired distance from the tipsof the tissue engaging element 170. In a further embodiment shown inFIG. 40G, a sealing member 140 may be attached to the ribs 114 such thatthe upstream edge 178 of the sealing member 140 can limit the depth ofpenetration of the tissue engaging element 170. In order to preventslippage of the sealing member 140 downward, an attachment feature suchas a hole 173 configured to receive a suture may be formed in the rib114 at the desired distance from its upstream tip 175 to which thesealing member 140 can be firmly secured.

Alternatively, tissue engaging elements 170, such as bumps, ridges, orother protrusions configured to exert frictional forces on cardiactissue, may be also present on one or more valve support struts 124,valve support posts 122, and/or other components (e.g., sealing members140). These tissue engaging elements 170 can be disposed on an outerportion of these features and can be configured to extend outwardly toengage the native leaflets and to stabilize and firmly anchor the device100 in the desired location. Alternatively, ridges, scales, bristles, orother features having directionality may be formed on the surface of theribs 114, connectors 116, or sealing member 140 to allow movementrelative to native tissue in one direction, while limiting movement inthe opposite direction.

The tissue engaging elements 170 on the anchoring member 110 can bebarbs, spikes, or other retention features configured to have a delayeddeployment so as to allow the device to be repositioned or removed for aperiod of time until these elements become fully deployed. For example,the tissue engaging element 170 may be constructed of a shape memorymaterial (e.g., Nitinol) which is preshaped in a deployed configurationand adapted to retain the tissue engaging element 170 in the nativetissue. The tissue engaging element 170 may be deformed into acontracted configuration which permits removal from tissue, and retainedin this shape by a bioerodable material or adhesive. Once immersed intissue, this material can erode over a period of time (e.g., 10minutes-2 hours) allowing the tissue engaging element 170 to return toits unbiased deployed shape which will assist in retaining the tissueengaging element 170 in the tissue.

Several examples of such delayed, deployable tissue engaging elements170 are shown in FIGS. 40I-40T. In the embodiment of FIG. 40I, thetissue engaging element 170 comprises a shape memory alloy shaft 450laser cut so as to have a diamond-shaped window 451 near its distal tip452, which can be sharp enough to penetrate tissue. The shape set sothat window 451 is biased toward being open in an expanded configurationas shown in FIG. 40I. Prior to delivery of the device, window 451 may bepinched closed and a bioerodable glue 455 may be injected into window451 to hold it in a closed configuration as shown in FIG. 40J. Upondeployment of the device, the distal tip 452 can penetrate the nativetissue, e.g. valve leaflet or annulus, as shown in FIG. 40K. The glue455 within window 451 maintains it in a closed configuration for aperiod of time to allow the operator to reposition or remove the deviceif necessary. If left in position, the glue 455 erodes, allowing thewindow 451 to reopen into the expanded configuration which will retainthe tissue engaging element 170 in the tissue as shown in FIG. 40L.

In the embodiment shown in FIGS. 40M-40P, the tissue engaging element170 comprises an arrowhead-shaped tip 453 having two or more wings 454biased to be angled radially outward and pointing in a proximaldirection as shown in FIG. 40M. A bioerodable glue or coating 455 isapplied over the arrowhead tip 453 to hold the wings 454 in a radiallycontracted configuration as shown in FIG. 40N. In the contractedconfiguration, the device 100 is deployed such that the tissue engagingelement 170 pierces the native tissue as shown in FIG. 40O. Thebioerodable coating 455 then erodes gradually until it allows the wings454 to return to the laterally expanded configuration shown in FIG. 40P,thus retaining the tissue engaging element 170 in the tissue.

A further embodiment is shown in FIGS. 40Q-40T. In this embodiment, thetissue engaging element 170 comprises a helical tip 456 in an unbiasedstate. A bioerodable coating 455 may be used to retain the helical tip456 in a straightened configuration as shown in FIG. 40R. The tissueengaging element 170 can penetrate the tissue in the contractedconfiguration, and when the bioerodable coating 455 erodes sufficientlyto allow the helical tip 456 to return to its deployed configuration,the tissue engaging element 170 can be retained in the tissue.

The prosthetic heart valve device 100 can also be configured to haveadditional tissue engaging elements 170 for engaging the annulus. Forexample, FIG. 41 is an isometric view of a prosthetic heart valve device100 having a plurality of annulus engaging elements 179 in accordancewith a further embodiment of the present technology. The annulusengaging elements 179 can be a C-shaped hook feature or other shape thatallows the element 179 to engage tissue on the annulus, as well as aportion of supra-annular tissue and subannular tissue. As shown, theannulus engaging elements 179 can be symmetrically (shown in FIG. 41) orasymmetrically interspersed around the upstream perimeter of theanchoring member 110 and coupled to ribs 114, connectors 116 (notshown), or to a sealing member 140. The annulus engaging elements 179may also be coupled to the anchoring member 110 at other locationsdownstream of the upstream perimeter 113, or in other embodiments to aportion of the valve support 120 that extends through at least theannulus plane PO (FIG. 3). Additionally, the annulus engaging elements179 may be blunt (e.g., for pressing but not penetrating into theannular tissue), or they may be sharp for penetrating the annulus tissueon either or both of the supra-annular or subannular surfaces. Theannulus engaging element 179 can be suitable for both positioning thedevice 100 in the desired location (e.g., with anchoring member 110below the annulus), as well as to inhibit movement of the device ineither an upstream or downstream direction.

In another embodiment shown in FIGS. 42A-42B, a prosthetic heart valvedevice 100 can have tissue engaging elements 372 deployable from aplurality of tubular ribs 314. Referring to FIG. 42A, the prostheticheart valve device 100 can have an anchoring member 110 having aplurality of tubular ribs 314 configured to retain a plurality ofdeployable tissue engaging elements 372. FIG. 42B is an enlarged view ofthe tubular rib 314 and a deployable tissue engaging element 372retained within a lumen 316 of the rib 314 and shown before deploymentof the element 372. The tissue engaging element 372 can comprise a shapememory material (e.g., Nitinol) configured to deploy to a preformedshape upon release of the tissue engaging element 372 from the innerlumen 316 of the rib 314. Release of the tissue engaging element 372 canbe achieved by engaging a proximal end 374 of the tissue engagingelement 372. For example, the proximal end 374 can be engaged during thedeployment of the device 100 to release the tissue engaging element 372after the anchoring member 110 is positioned at the desired locationbelow the annulus AN. The tubular rib 314 can include a U-shapeddeflector 318 and a pivot point 320 configured to guide the tissueengaging element 372 distally through a distal opening 315 of the rib314. As illustrated in dotted lines in FIG. 42B, engagement of theproximal end 374 of element 372 will encourage a distal end 376 of thetissue engaging element 372 from the distal opening 315 of the tubularrib 314 to penetrate adjacent subannular tissue. Once deployed and afterexiting an opposing surface S, such as the supra-annular surface, thetissue engaging element 372 can transition into its preformed shape,such as a curled shape 378 that can resist retraction of the distal end376 from the tissue.

In accordance with another embodiment of the prosthetic treatment device100, tissue engaging elements 170 can be incorporated into sealingmembers 140 (e.g., sleeve 146). FIGS. 43A-43B are an isometric view andan enlarged detail view of a prosthetic heart valve device 100 having asealing member 140 configured with tissue engaging elements 170.Referring to FIGS. 43A-43B together, the tissue engaging elements 170can comprise metallic or polymeric wires 274 or fibers, rigid and sharpenough to penetrate tissue, which are woven into or otherwise coupled tosealing member 140 materials. The sealing member 140 can then beattached to outer and/or inner walls 141, 142 of the anchoring member110 and/or interior and/or exterior surfaces 126, 127 of the valvesupport 120 such that tissue engaging elements 170 extend radiallyoutward from the sealing member 140 to engage the adjacent leaflets orother tissue.

Tissue engaging elements 170 may alternatively comprise an array ofrelatively short barbs, points, rods, tines, or similar protrusionsconfigured to frictionally engage the tissue, or dent or slightlypenetrate the surface of the tissue, to inhibit motion of the anchoringmember 110 relative to the native leaflets or annulus. These tissueengaging elements, in exemplary embodiments, may be polymeric ormetallic, about 0.2-5 mm in length, about 0.1-0.5 mm in diameter,flexible enough to deflect slightly in engagement with tissue, anddistributed over the surface of the sealing member 140 in densities of4-100 per square centimeter. The tissue engaging elements 170 may beintegrally formed with the material of the sealing member 140, woveninto such material, or formed in or mounted to a flexible sheet which isbonded, riveted, or otherwise fastened to the sealing member 140. Thetissue engaging elements 170 may be angled, curved, or bent so as topoint preferentially in a non-perpendicular direction, preferably in anupstream direction, to impart higher retention force against movement inthe upstream direction while allowing movement more easily in thedownstream direction. In some embodiments, the tissue engaging elementsmay be composed of a bioerodable material that lasts, followingimplantation, a sufficient time to allow tissue ingrowth orencapsulation to retain the device 100 in position. The tissue engagingelements 170, and/or the material of sealing member 140, may also becoated with a permanent or temporary friction-enhancing coating oradhesive that enhances retention at least until the device has beenencapsulated in tissue sufficiently to prevent movement.

FIGS. 44A-44F are enlarged side views of embodiments of additionaltissue engaging elements that can be incorporated on various devicestructures (referred collectively as “ST”), such struts, connectors,posts, arms, and/or ribs which may be incorporated into device features,such as the anchoring member 110 or valve support 120. For example, theadditional tissue engaging elements may comprise one or more cut-outprotrusions 350 (FIGS. 44A and 44B) in place of or in addition to tissueengaging elements 170. In a collapsed or straightened configuration, asshown by the side view of FIG. 44C, cut-out protrusion 350 maintains lowrelief relative to the surface of structure ST to maintain a low profileduring delivery. As the device 100 expands and structure ST changes toits deployed configuration (e.g. a curvature as shown in FIG. 44D), theprotrusion separates from the ST to a higher relief. The protrusion 350may also be configured to grab subannular tissue, pulling the cut-outprotrusions even farther away from structure ST. The device structuresST may also be shaped to include sharp protrusions 352 along one or moreof its edges or faces, as illustrated in FIG. 44E, or may also includepointed scale-like protrusions 354, as shown in FIG. 44F.

In addition to the stabilizing members 501 described above, theprosthetic heart valve devices described herein (e.g., devices 100) mayalso include support features such as tethers 360 and sealing membersepta 370 for stabilizing the anchoring member 110 and/or the valvesupport 120, and/or for spreading pressure gradient loads evenly over agreater area of the device 100 (e.g., during ventricular systole).Referring to FIG. 45A, one example of the device 100 can incorporate aplurality of tethers 360 at least loosely coupling the upper portion 112of the anchoring member 110 to the upstream end 121 of the valve support120. In one embodiment, the tethers 360 can include a single suture thatis run continuously around the circumference 150 of the anchoring member110. In another embodiment, the device 100 can include several suturesof discreet lengths tied between the anchoring member 110 and the valvesupport 120. In one embodiment the tethers can be a suture comprisingpolytetrafluoroethylene (PTFE). Generally, the tethers 360 assist indistributing forces evenly along the anchoring member 110 withoutdeforming the valve support 120 or compromising the closure of theprosthetic valve 130. In some arrangements, the tethers 360 can assistin limiting radial expansion of the upstream portion. Accordingly, evenwith the incorporation of the tethers 360, the valve support 120 remainsmechanically isolated from at least the upstream portion of theanchoring member 110.

FIG. 45B shows another example of a stabilizing member 501 suitable tostabilize the anchoring member 110 and/or the valve support 120, and/orfor spreading pressure gradient loads evenly over a greater area of thedevice 100 (e.g., during ventricular systole). As shown in FIG. 45B, thedevice 100 can include a plurality of sealing member septa 370 extendingbetween the anchoring member 110 and the valve support 120. In theillustrated embodiment, the septa 370 can be extensions of the sealingmember material configured to span between a sealing member 140, such asa skirt 144, coupled to the inner wall 141 of the anchoring member 110and a sealing member 140, such as a sleeve 146, coupled to an interioror exterior surface 126, 127 of the valve support 120. Accordingly, thesepta 370 can be formed of fabric or other flexible and biocompatiblematerials such as Dacron®, ePTFE, bovine pericardium, or other suitablematerials. Similar to the embodiment illustrated in FIG. 45A, the septa370 can assist in distributing forces evenly along the anchoring member110 without deforming the valve support 120 or otherwise compromisingthe closure of the prosthetic valve 130. In some arrangements, the septa370 can assist in preventing the device 100 from everting duringventricular systole. Accordingly, even with the incorporation of thesepta 370, the valve support 120 is mechanically isolated from at leastthe upstream portion of the anchoring member 110.

Each of the elements and members of the device 100 may be made from anynumber of suitable biocompatible materials, e.g., stainless steel,nickel titanium alloys such as Nitinol™, cobalt chromium alloys such asMP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers,pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or anynumber of other materials or combination of materials depending upon thedesired results. The arm members 510, sealing member 140, sleeves 146,anchoring member 110 and/or valve support 120 or other elements ofdevice 100 may also be coated or covered with a material that promotestissue in-growth (e.g., Dacron®, PTFE, etc.)

Delivery Systems

FIGS. 46A-46D illustrate one embodiment of a delivery system 10 suitablefor delivery of the prosthetic heart valve devices disclosed herein. Asused in reference to the delivery system, “distal” refers to a positionhaving a distance farther from a handle of the delivery system 10 alongthe longitudinal axis of the system 10, and “proximal” refers to aposition having a distance closer to the handle of the delivery system10 along the longitudinal axis of the system 10.

FIG. 46A illustrates one embodiment of the delivery system 10 which maybe used to deliver and deploy the embodiments of the prosthetic heartvalve device 100 disclosed herein through the vasculature and to theheart of a patient. The delivery system 10 may optionally include aguiding catheter GC having a handle 12 coupled to a delivery shaft 16,which in one embodiment is 34 F or less, and in another embodiment, 28 For less in diameter. The guiding catheter GC may be steerable orpreshaped in a configuration suitable for the particular approach to thetarget valve. The delivery catheter 18 is placed through a hemostasisvalve HV on the proximal end of guiding catheter GC and includes aflexible tubular outer shaft 19 extending to a delivery sheath 20 inwhich the device 100 is positioned in a collapsed or deliveryconfiguration 106. A flexible inner shaft 28 is positioned slideablywithin outer shaft 19 and extends through the device 100 to a nosecone21 at the distal end. The inner shaft 28 has a guidewire lumen throughwhich a guidewire 24 may be slideably positioned. The device 100 iscoupled to the inner shaft 28 and is releasable from the inner shaft 28by release wires 30, as more fully described below. The delivery sheath20 can protect and secure the device 100 in its collapsed configuration106 during delivery. The outer shaft 20 is coupled to a retractionmechanism 23 on the handle 14 of the delivery catheter 18. Variousretraction mechanisms 23 may be used, such as an axially-slidable lever,a rotatable rack and pinion gear, or other known mechanisms. In thisway, the outer shaft 20 may be retracted relative to the inner shaft 28to release (e.g., deploy) the device 100 from the sheath 20.

FIG. 46B shows the distal end of the delivery catheter 18 with thesheath 20 cut away to illustrate the coupling of the device 100 to theinner shaft 28. A plurality of locking fingers 32 are coupled to thenose cone 21 and extend proximally through the interior of the valvesupport 120 of the device 100. As shown in FIG. 46C, a selected numberof posts 122 of the valve support 120 have a coupling element 61comprising a tab 34 cut out from each post 122 at a proximal endthereof. The tab 34 may be deflected inwardly from the post 122 as shownin FIG. 46B and is configured to extend through a window 42 in thelocking finger 32 as shown in FIG. 46D. The release wires 30 passthrough the holes 40 in the tabs 34, which prevents the tabs 34 frombeing withdrawn from the windows 42 to secure the device 100 to theinner shaft 28. The pull-wires 30 can be sandwiched tightly between thetabs 34 and the locking fingers 32, such that friction temporarilyprevents the pull-wire 30 from slipping in a proximal or distaldirection. In this way, the sheath 20 may be retracted relative to thedevice 100 to permit expansion of the device 100 while the inner shaft28 maintains the longitudinal position of the device 100 relative to theanatomy. The pull-wires 30 may extend proximally to the handle 14, forexample, in between the inner shaft 28 and the outer shaft 19 or withinone or more designated lumens. A suitable mechanism (not shown) on thehandle 14 can allow the operator to retract the release wires 30 in aproximal direction until they are disengaged from the tabs 34.Accordingly, the device 100 can be released from the locking fingers 32and expand for deployment at the target site.

FIGS. 47A-47D are schematic, cross-sectional side views of a heart Hshowing a trans-septal or antegrade approach for delivering anddeploying a prosthetic heart valve device 100. As shown in FIG. 47A, aguidewire 24 may be advanced intravascularly using any number oftechniques, e.g., through the inferior vena cava IVC or superior venacava SVC, through the inter-atrial septum IAS and into the right atriumRA. The guiding catheter GC may be advanced along the guidewire 24 andinto the right atrium RA until reaching the anterior side of the atrialseptum AS, as shown in FIG. 47B. At this point, the guidewire 24 may beexchanged for the needle 25, which is used to penetrate through theinter-atrial septum IAS (FIG. 47C). The guiding catheter GC may then beadvanced over the needle 25 into the left atrium LA, as shown in FIG.47D. The guiding catheter GC may have a pre-shaped or steerable distalend to shape or steer the guiding catheter GC such that it will directthe delivery catheter 18 (FIG. 46A) toward the mitral valve.

As an alternative to the trans-septal approach, the mitral valve mayalso be accessed directly through an incision in the left atrium. Accessto the heart may be obtained through an intercostal incision in thechest without removing ribs, and a guiding catheter may be placed intothe left atrium through an atrial incision sealed with a purse-stringsuture. A delivery catheter may then be advanced through the guidingcatheter to the mitral valve. Alternatively, the delivery catheter maybe placed directly through an atrial incision without the use of aguiding catheter.

FIGS. 48A-48C are cross-sectional views of the heart illustrating amethod of implanting a prosthetic heart valve device 100 using atrans-septal approach. Referring to FIGS. 48A-48C together, the distalend 21 of the delivery catheter 18 may be advanced into proximity to themitral valve MV. Optionally, and as shown in FIG. 48A, a guidewire GWmay be used over which catheter 18 may be slideably advanced over aguidewire GW. The sheath 20 of the delivery catheter 18, which containsthe device 100 in a collapsed configuration 106, is advanced through themitral valve annulus AN between native leaflets LF, as shown in FIG.48A. Referring to FIG. 48B, the sheath 20 is then pulled back proximallyrelative to the distal nose cone 27 allowing the device 100 to expandsuch that anchoring member 110 pushes the leaflets LF outwardly to foldbeneath the mitral valve annulus AN. The tips of the ribs 114 engage andmay penetrate into or through the leaflet tissue to further engage thetissue of the annulus AN. After the sheath 20 has been removed and thedevice 100 allowed to expand, the delivery system can still be connectedto the device 100 (e.g., system eyelets, not shown, are connected to thedevice eyelets 180, shown in FIG. 10A) so that the operator can furthercontrol the placement of the device 100 in the expanded configuration102. For example, the device 100 may be expanded upstream or downstreamof the target location then pushed downstream or upstream, respectively,into the desired target location before releasing the device 100 fromdelivery system 10. Once the device 100 is positioned at the targetsite, the pull-wires 30 (FIGS. 46A-46B) may be retracted in a proximaldirection, to detach the device 100 in the deployed configuration 104from the delivery catheter 18. The delivery catheter 18 can then beremoved as shown in FIG. 48C. Alternatively, the device 100 may not beconnected to the delivery system 10 such that the device 100 deploys andis fully released from the delivery system 10.

FIGS. 49A and 49B illustrate another variation for delivering anddeploying one or more prosthetic heart valve devices 100 using aretrograde approach to the mitral valve via the aorta and leftventricle. In this example, the guidewire GW may be advancedintravascularly from a femoral or radial artery or through direct aorticpuncture through the aorta AO and aortic valve AV, and into the leftventricle LV of the heart H (FIG. 49A). A guiding catheter GC, oralternatively, the delivery catheter 18, may be advanced along theguidewire GW until the distal end is positioned within the leftventricle in proximity to the mitral valve MV, as shown in FIGS. 49A and49B. In many arrangements, the guiding catheter GC and/or the deliverycatheter 18 will have a steering mechanism or a pre-shaped distal tipallowing it to be steered around the 180° turn from the aortic valve AVto the mitral valve MV. The distal end of the delivery catheter 18 mayoptionally be advanced at least partially through the mitral valve MVinto the left atrium LA.

FIGS. 50A-50B illustrate delivery of the device 100 in the collapsedconfiguration 106 to the mitral valve MV in a trans-apical approach.Referring to FIG. 50A, the delivery catheter 18 is advanced through aguiding catheter GC that has been inserted into the left ventricle ofthe heart through a puncture in the left ventricle wall at or near theapex of the heart. The catheter can be sealed by a purse-string suture.Alternatively, the delivery catheter 18 may be placed directly through apurse-string-sealed trans-apical incision without a guiding catheter.The sheath 20 and the device 100 (e.g., in the collapsed configuration106) within the sheath 20 are advanced through the mitral annulus ANbetween native leaflets LF as shown in FIG. 50A. Referring to FIG. 50B,the sheath 20 is pulled proximally such that the device 100 expands tothe expanded and/or deployed configurations 102, 104. The deliverysystem 10 can remain connected to the device 100 (e.g., system eyelets,not shown, are connected to the device eyelets 180, FIG. 10A) afterremoving the sheath 20 so that the operator can control the placement ofthe device 100 while in the expanded configuration 102. The pull-wires30 may be retracted in a proximal direction to release the device 100from the delivery system 10, allowing the delivery system 10 to beremoved and the device to be fully implanted at the mitral valve MV inthe deployed configuration 104. In one embodiment, the device 100 may beexpanded upstream or downstream of the desired target location thenpulled or pushed downstream or upstream, respectively, into the targetlocation before releasing the device 100 from delivery system 10.Alternatively, the device 100 may not be connected to the deliverysystem 10 such that the device 100 deploys and is fully released fromthe delivery system 10.

FIGS. 51A-51B are partial side views of a delivery system 10 wherein aprosthetic heart valve device 100 is mounted on an expandable balloon300 of a delivery catheter 18 in accordance with another embodiment ofthe present technology. Referring to FIGS. 51A and 51B together, thedevice 100 can be mounted on an expandable balloon 300 of a deliverycatheter while in a collapsed configuration 106 and delivered to thedesired location at or near a native mitral valve (FIG. 51A). When thedevice 100 is released from the sheath 20 (FIGS. 46A-46B), the device100 can be expanded to its expanded configuration 102 by inflation ofthe balloon 300 (FIG. 51B). When using a balloon 300 with the deliverysystem 10, the device 100 can be advanced from the delivery shaft 16 toinitially position the device 100 in a target location. The balloon 300can be inflated to fully expand the device 100. The position of thedevice 100 relative to the mitral valve may then be adjusted using thedevice locking hub to position the device into desired implantation site(e.g., just below the annulus of the native mitral valve). In anotherembodiment, the balloon 300 can initially be partially inflated topartially expand the device 100 in the left atrium. The delivery system10 can then be adjusted to push or pull (depending on the approach) thepartially expanded heart valve device 100 into the implantation site,after which the device 100 can be fully expanded to its functional size.In other alternative methods, the anchoring member 110 is aself-expanding construct which is first released from a sheath 20 (FIGS.46A-46B) at the target site to engage the native anatomy, while thevalve support 120 is a balloon-expandable element mounted on a balloon300 which is then expanded to fully deploy the valve support 120 afterthe anchoring member 110 has been released.

In still further embodiments, the valve support 120 of device 100 may beconfigured to be axially movable or detachable from the anchoring member110. In such arrangements, the two components 110, 120 may be loaded inan axially separated configuration within the delivery system 10,thereby reducing the overall profile of the system 10. After delivery tothe target valve site, the components 110, 120 can be assembledtogether. FIGS. 52A-52D show an embodiment of assembling the valvesupport 120 and anchoring member 110 in the heart. As shown in FIG. 52A,the delivery catheter 380 is advanced into the left atrium via a guidingcatheter GC placed through the inter-atrial septum or the atrial wall.The delivery catheter 380 has a split sheath 382, 384 comprising adistal nose cone 382 and a proximal capsule 384. The delivery catheter380 is advanced through the native valve MV until the nose cone 382 ispositioned distally of the native annulus AN (FIG. 52A). The nose cone382 is then advanced further distally while maintaining the position ofthe remainder of the delivery catheter 380 thereby releasing theanchoring member 110 from the nose cone 382 (FIG. 52B). The anchoringmember 110 self-expands outward, engaging the native leaflets LF andfolding them outward beneath the native annulus AN, as shown in FIG.52B. The upstream tips of ribs 114 (FIG. 52B) engage the subannulartissue to anchor the device 100 in position. The sealing member 140 isfixed around the perimeter 113 of the anchoring member 110 and has aconnecting portion 386 extending into the proximal capsule 384 where itis fixed to the valve support 120, which is still constrained within theproximal capsule 384. The delivery catheter 380 is then advanced so asto position the proximal capsule 384 within the anchoring member 110 asshown in FIG. 52C. By advancing the catheter 380 until the sealingmember 140 becomes taught, the proper positioning may be attained. Theproximal capsule 384 is then retracted relative to the nose cone 382 torelease the valve support 120 from the proximal capsule 384. The valvesupport 120 can self-expand into engagement with the downstream end ofanchoring member 110 to couple the two components together. The deliverycatheter 380 may then be withdrawn from the patient.

FIGS. 53A-53H show various mechanisms that may be used for coupling thevalve support 120 to the anchoring member 110 in the process shown inFIGS. 52A-52D. For example, as shown in FIG. 53A, the valve support 120may include a circumferential ridge or detent 388 near its downstreamend that engages in a groove 390 in the anchoring member 110 to inhibitdetachment of the two components. Alternatively, valve support 120 mayhave a hook 392 formed at the downstream end of each post 122 which isconfigured to extend around a downstream end of anchoring member 110,e.g. around either the downstream tip of rib 114 or connectors 116, asshown in FIGS. 53B-53C. For example, the hook 392 may be configured toflex inwardly when it engages the inner surface of the rib 114 as thevalve support 120 is advanced, and be configured to resiliently recoilto its outward configuration when extended beyond the downstream end ofthe rib 114, as shown in FIG. 53C. Optionally, a depth-limiting featuresuch as a stub 394 may extend outwardly from the valve support 120 whichis configured to engage a complementary feature such as a bump or ridge396 on the anchoring member 110 to prevent insertion of the valvesupport 120 beyond a predetermined depth.

In a further embodiment shown in FIGS. 53D-53F, the valve support 120may have a coupling element 398 on its outer surface configured toslideably couple to the anchoring member 110. In a first configuration,the coupling element 398 comprises a loop 40O, shown in FIG. 53E,through which a vertical guide member 402 on the anchoring member 110may slide. The anchoring member 110 may have a plurality of such guidemembers 402 extending upwardly from its downstream end at locationsspaced around its circumference. A bump 404 may be formed near thedownstream end of each guide member 402 over which the loop 400 mayslide to inhibit the valve support 120 from sliding back in the upstreamdirection (FIG. 53D). In an alternative configuration, shown in FIG.53F, the guide member 402 has a vertical slot 406 into which a radiallyextending pin 408 on the valve support 120 can extend. The pin 408 mayslide to the downstream end of the slot 406 where it may be urgedthrough a waist 411, which prevents the pin 408 from sliding back in theupstream direction.

In a further embodiment shown in FIGS. 53G-53H, coupling elements 398 onthe valve support 120 are configured to slideably receive the ribs 114,which themselves perform a similar function as the guide members 402(described with respect to FIGS. 53D-53F). As shown in FIG. 53G,coupling of the ribs 114 to the valve support 120 helps restrain theribs 114 in a radially compact configuration when the valve support 120slides axially upward relative to the anchoring member 110. In thearrangement shown in FIGS. 53GG-53H, the delivery of the device 100 maynot require the need for a separate sheath to constrain the ribs 114during the delivery. As shown in FIG. 53H, the valve support 120 mayslide in the downstream direction relative to the anchoring member 110until the ribs 114 assume their radially outward configuration. As withguide members 402, each rib 114 may have a bump 412 formed near itsdownstream end past which coupling element 398 may be urged, but whichthen inhibits valve support 120 from sliding in the upstream direction(FIG. 53H).

FIGS. 54A-55C illustrate a delivery catheter 400 of a delivery system 40in accordance with additional embodiments of the present technology.FIG. 54A is a cross-sectional side view of the delivery system 40 forthe prosthetic heart valve device 100 and FIG. 54B is a partialcross-sectional side view of a distal portion of the delivery system 40shown in FIG. 54A. As shown in FIGS. 54A and 54B, the delivery catheter400 comprises a sheath 402 having an outer wall 403 and a closed distalnose 406 defining a blind annular cavity 408. An inner wall 405 extendsproximally to the proximal end of the catheter (not shown), thus forminga tubular catheter shaft 407 defining an inner lumen extending axiallytherethrough in which a guidewire GW may be slideably positioned. Apiston 412 is slideably disposed in the cavity 408 and has an O-ring 413around its circumference to create a fluid seal with the wall of thecavity 408. A tubular piston shaft 414 extends proximally from piston412 and is slideably mounted over the catheter shaft 407. The pistonshaft 414 is oversized relative to the catheter shaft 407 so as todefine a fluid lumen 416 which is in communication with the cavity 408.The device 26 is retained in its radially collapsed deliveryconfiguration within cavity 408, with piston shaft 414 and cathetershaft 407 extending through the interior of the valve support 120 (shownin FIGS. 55A-55C). Preferably, the device 100 is releasably coupled topiston 412 by, for example, pins (not shown) extending radiallyoutwardly from piston shaft 414.

The sheath 402 may have features that limit its travel. For example, awire (not shown) may tether the protective sheath to a handle on theproximal end of catheter 400. The wire may be attached to an adjustablestop on the handle, allowing the length of piston travel to be adjusted.When fluid is injected into cavity 408, piston 412 will travel untilthis stop is reached. In this manner, the deployment progression can becontrolled.

To ease the retraction of sheath 402 through the valve of the device 100following deployment, a tapered feature may advance to abut the proximalend of the sheath 402 (see FIG. 56). Alternatively, piston 412 may havea taper or soft bumper material affixed directly to the back of piston412 facing in the proximal direction. In this way the proximal side ofthe piston would itself provide an atraumatic leading surface to easeretraction of the sheath 402 through the valve support 120.

Features intended to control and smooth the deployment of device 100 canbe incorporated. For example, a common problem during deployment ofself-expanding stents is a tendency of the deployed device to “pop” orjump forward or backward as the final elements exit the deploymentdevice. Features to prevent the sheath 402 from being thrust forward bythe expanding skeletons of the device 100 may be important in order toprevent accidental damage to the ventricle or other tissue. Suchfeatures may incorporate stops or tethers within the deployment systemdesigned to retain the position of the sheath 402 relative to thedeployed device 100. For example, the proximal edge of the sheath 402could be swaged slightly inward to prevent the piston from exiting thesheath and to precisely locate the taper or bumper features describedabove to ease withdrawal of the system through the deployed valve.Alternatively or additionally, a spring mechanism (not shown) could bebuilt into the delivery system 40 so that when the last features of thedevice 100 leave the sheath 402, the sheath actively retracts slightlyinto the downstream end of the newly deployed device 100.

The operation of the delivery catheter 400 is illustrated in FIGS.55A-55C. The delivery catheter 400 is positioned at the target valvesite using one of the approaches described elsewhere herein. Thedelivery catheter 400 is particularly well suited to placement throughthe native valve from the upstream direction. The catheter 400 isadvanced until the sheath 402 is positioned downstream of the nativeannulus (FIG. 55A). Fluid can then be injected through fluid lumen 416into the cavity 408, distal to the piston 412 (FIG. 55B). This drivesthe sheath 402 distally, releasing the device 100 from the cavity 408(FIG. 55C). The delivery catheter 400 and the device 100 may remain in astationary longitudinal position relative to the native valve while thedevice 100 is deployed, thereby increasing the precision of deployment.In addition, the device 100 may be deployed in a slow and controlledmanner, avoiding sudden and uncontrolled jumps of the device 100.Further, such hydraulic actuation allows the sheath 402 to be moved inincremental steps to only partially deploy the device 100, allowing theoperator to assess its position relative to the native valve andreposition as needed before complete deployment.

In one embodiment, the piston 412 can be hydraulically actuated,however, in another embodiment, the piston 412 could be operated bymanual retraction of the piston shaft 414 or advancement of the sheath402. The delivery catheter 400 may be equipped with a handle on itsproximal end having a retraction mechanism coupled to the piston shaft414 and/or catheter shaft 407. Such a mechanism may use gears or pulleysto provide a mechanical advantage to reduce the force required toretract the piston or advance the sheath.

The delivery catheters in accordance with aspects of the presenttechnology may further be configured to be reversible, to allow thedevice 100 to be retracted back in to the catheter 400 after a full orpartial deployment. One embodiment of such a catheter is illustrated inFIG. 56, wherein the delivery catheter 400 of FIGS. 54A-55C is adaptedto retract the device 100 back into the sheath 402 after being fully orpartially deployed therefrom. The piston 412 has at least a first pulley420 coupled thereto, while distal nose 406 has at least a second pulley422 coupled thereto. A plurality of additional pulleys 423 may also beprovided at locations around the circumference of the piston 412 foradditional mechanical assistance. A cable 424, which may comprise alength of wire or suture, extends through the fluid lumen 416 and cavity408, passes around first and second pulleys 420, 422 and any additionalpulleys 423, and is secured to piston 412. The device 100 can bereleasably coupled to the piston shaft 414 by a plurality of pins 426extending radially from the piston shaft 414 into engagement with thedevice 100, preferably near a downstream end 428 thereof.

To deploy the device 100, the delivery catheter 400 of FIG. 56 operatessimilarly as described above in connection with FIGS. 55A-55C; however,in an additional embodiment and before the downstream end 428 has beenfully released from the sheath 402, the operator can checks the locationof the device 100. Upon deployment, the upstream end 430 of the device100 will expand toward its expanded configuration. An operator can view,using ultrasound, fluoroscopy, MRI, or other means, the position andshape of the deployed device 100 in the native tissue. Followingpositioning, the sheath 402 may be further advanced relative to thepiston 412 to fully deploy the device 100 from the sheath 402, whereuponthe downstream end 428 fully expands and pins 426 are disengaged fromdevice 100. In situations where the operator desires to recover thedevice 100 back into the sheath 402 for repositioning or other reasons,the cable 424 is pulled so as to move the piston 412 in the distaldirection relative to the sheath 402. The pins 426 pull the device 100with the piston 412 back into the sheath 402 and the device 100 iscollapsed as it is pulled in the sheath 402. The delivery catheter 400may then be repositioned and the device redeployed.

In one embodiment, the prosthetic heart valve device 100 may bespecifically designed for a specific approach or delivery method toreach the mitral valve, or in another embodiment, the device 100 may bedesigned to be interchangeable among the approaches or delivery methods.

Additional Embodiments of Prosthetic Heart Valve Devices, DeliverySystems and Methods

FIGS. 57A-57E are isometric views of prosthetic heart valve devices 600shown in an expanded configuration 602 and configured in accordance withadditional embodiments of the present technology. The prosthetic heartvalve devices 600 include features generally similar to the features ofthe prosthetic heart valve device 100 described above with reference toFIGS. 10A-56. For example, the prosthetic heart valve device 600includes the valve support 120 configured to support a prosthetic valve130 and an anchoring member 610 coupled to the valve support 120 in amanner that mechanically isolates the valve support 120 from forcesexerted upon the anchoring member 610 when implanted at the nativemitral valve. However, in the embodiments shown in FIGS. 57A-57E, anupstream region 612 of the anchoring member 610 is coupled to the valvesupport 120 such that a downstream region 611 of the anchoring member610 is configured to engage native tissue on or downstream of theannulus so as to prevent migration of the device 600 in the upstreamdirection.

FIGS. 57A and 57B illustrate embodiments of the device 600 wherein theanchoring member 610 includes a plurality of longitudinal ribs 614coupled to the upstream end 121 of the valve support 120 and extendingin a downstream to distal direction. As shown in FIG. 57A, the ribs 614can project radially outward away from the longitudinal axis 101 at thedownstream region 611 of the anchoring member 610 such that thedownstream region 611 is flared outward for engaging subannular tissuebelow the mitral annulus. FIG. 57B illustrates an embodiment of thedevice 600 having an anchoring member 610 with an upward-facing lip 617at the downstream region. In this embodiment, the ribs 614 can be formedsuch that the downstream region is generally flared outwardly from thelongitudinal axis 101 but the tips 615 of the ribs 614 reorient to pointin an upstream direction at the lip 617. The lip 617 may assist theanchoring member 610 in engaging subannular tissue and can be configuredto include tissue engaging elements (not shown) as described above withrespect to device 100. The anchoring member 610 can also be coupled tothe valve support 120 at a position desirable for positioning the valvesupport 120 and prosthetic valve 130 within the native valve. Forexample, FIG. 57C illustrates an embodiment of the device 600 in whichthe anchoring member 610 can be coupled to the valve support 120 at alocation downstream from the upstream end 121.

Referring to FIGS. 57A-57C together, the anchoring member 610 can have afirst cross-sectional dimension D_(C1) at the upstream region 612 thatis less than a second cross-sectional dimension D_(C2) at the downstreamregion 611. Additionally, the valve support 120 is radially separatedfrom the downstream region 611 of the anchoring member 610 such thatwhen the device 600 is deployed, the downstream region 611 can deforminwardly without deforming the upstream portion of the valve support120. Additionally, the anchoring member 610 can have a generally oval orD-shape, or other irregular shape such as those described above withrespect to FIGS. 16A-17C, while the valve support 120 can be generallycylindrical in shape. In such embodiments, the second cross-sectionaldimension D_(C2) can be greater than a corresponding cross-sectionaldimension (e.g., MVA1 or MVA2) of the annulus of the native mitral valve(FIG. 5C).

FIG. 57D illustrates yet another embodiment of the device 600 in anexpanded configuration 602. As shown, the valve support 120 can includea flange 620 at the downstream end 123 of the valve support 120. Theflange 620 can extend radially outward from the longitudinal axis 101 atthe downstream end 123 to radially engage subannular tissue. Theanchoring member 610 can include a plurality of ribs 614 coupled to theupstream end 121 of the valve support 120 and extending radially outwardin the downstream direction to attach to an outer rim 622 of the flange620. The anchoring member 610 can be configured to engage subannulartissue, such as inward-facing surfaces of the leaflets. In thisembodiment, the ribs 614 can be flexible such that deformation of theanchoring member 610 between the coupling at the upstream region 612 andthe coupling to the flange 620 at the lower region 611 will notsubstantially deform the valve support 120 wherein a prosthetic valve isconnected.

FIG. 57E is a schematic cross-sectional view of the prosthetic heartvalve device 600 of FIG. 57A implanted at a native mitral valve MV inaccordance with an embodiment of the present technology. As shown, theflared downstream region 611 of the anchoring member 610 can engage thesubannular tissue, e.g., inward-facing surfaces of the leaflets LF, asubannular surface, etc. The ribs 614 can incorporate tissue engagingelements 170 on the rib tips 615 for penetrating and/or partiallypenetrating the tissue. Further, the anchoring member 610 can expandradially outward to seal (not shown) against the tissue to preventmigration of the device 600 in the upstream or downstream directionand/or to prevent paravalvular leaks between the tissue and the device600. Accordingly, the device 600 can incorporate one or more sealingmembers 140 as described above with respect to device 100. Additionally,the device 600 can also include an atrial extension member or atrialretainer 410 (shown in dotted lines) as described above with respect tothe device 100. The atrial retainer, if present, can be configured toengage tissue above the annulus AN such as a supra-annular surface orsome other tissue in the left atrium LA to inhibit downstream migrationof the device (e.g., during atrial systole).

FIGS. 58A-58D are cross-sectional views of a heart showing a method ofdelivering a prosthetic heart valve device 600 to a native mitral valveMV in the heart using a trans-apical approach in accordance with anotherembodiment of the present technology. Referring to FIG. 58A, thedelivery catheter 18 is advanced through guiding catheter (not shown)which enters the left ventricle LV of the heart through a puncture inthe left ventricle wall at or near the apex of the heart and is sealedby a purse-string suture. Alternatively, the delivery catheter 18 may beplaced directly through a purse-string-sealed trans-apical incisionwithout a guiding catheter. The sheath 20, containing a collapsed device600, 606 (shown in FIG. 58B), is advanced through the mitral annulus ANbetween native leaflets LF as shown in FIG. 58A. Referring to FIGS.58B-58D together, the sheath 20 is pulled proximally to allow the device600 to expand to the expanded and/or deployed configurations 602, 604(FIGS. 58C and 58D).

Although the sheath 20 can be retracted and the device 600 allowed toexpand, the delivery system can remain connected to the device 600(e.g., system eyelets, not shown, are connected to the device eyelets,not shown) such that the operator can control the placement of thedevice 600 while in the expanded configuration 602 (FIGS. 58C and 58D).For example, as the sheath 20 is disengaged from the device 600, theupstream region 612 of the anchoring member 610 can remain collapsedwithin the sheath preventing the anchoring member 610 from fullyexpanding (FIG. 58C). During this phase of the delivery, the position ofthe device 600 within the mitral valve area can be adjusted or altered.After the device 600 is located at the target site, the sheath 20 can befully removed from the device 600 and the anchoring member 610 of thedevice 600 can expand outwardly at the downstream region 611 to engagesubannular tissue, such as the leaflets LF, and to retain the device 600in the desired target location. The pull-wires (not shown) may beretracted in a proximal direction to release the device 600 from thedelivery system, allowing the delivery system to be removed and thedevice to be fully implanted at the mitral valve MV in the deployedconfiguration 104. Alternatively, the device 600 may be expandedupstream or downstream of the desired target location then pulled orpushed downstream or upstream, respectively, into the target locationbefore releasing the device 600 from delivery system.

FIGS. 59A-59C are isometric views of prosthetic heart valve devices 700shown in an expanded configuration 702, and FIG. 59D is a schematiccross-sectional view of the prosthetic heart valve device 700 implantedat a native mitral valve configured in accordance with furtherembodiments of the present technology. The prosthetic heart valvedevices 700 include features generally similar to the features of theprosthetic heart valve devices 100 and 600 described above withreference to FIGS. 10A-58D. For example, the prosthetic heart valvedevice 700 includes the valve support 120 configured to support aprosthetic valve 130 and a first anchoring member 610 coupled to thevalve support 120 in a manner that mechanically isolates the valvesupport 120 from forces exerted upon the first anchoring member 610 whenimplanted at the native mitral valve. Particularly, the upstream region612 of the first anchoring member 610 is coupled to the valve support120 and the downstream region 611 of the first anchoring member 610 isconfigured to flare outwardly to engage native tissue on or downstreamof the annulus so as to prevent migration of the device 600 in theupstream direction. However, in the embodiments shown in FIGS. 59A-59D,the device 700 also includes a second anchoring member 710 having adownstream region 711 coupled to the valve support 120, and an upstreamregion 712 extending radially outward in the upstream direction.Accordingly, the device 700 includes both the first and second anchoringmembers 610 and 710 for engaging tissue on or under the annulus of themitral valve.

Referring to FIGS. 59A-59D together, the first anchoring member 610 canhave the first cross-sectional dimension D_(C1) at the upstream region612 that is less than the second cross-sectional dimension D_(C2) at thedownstream region 611. The second anchoring member 710 can have a thirdcross-sectional dimension D_(C3) at the upstream region 712 that isgreater than a fourth cross-sectional dimension D_(C4) at the downstreamregion 711. In some embodiments, the third cross-sectional dimensionD_(C3) is less than the second cross-sectional dimension D_(C2) suchthat the second anchoring member 710 can be partially surrounded by thefirst anchoring member 610 (FIG. 59A). In such an embodiment, theupstream region 712 can apply radial outward pressure against an innerwall (not shown) of the first anchoring member 610 and further supportthe fixation of the first anchoring member 610 to the tissue on or underthe annulus. In another embodiment shown in FIG. 59B, the thirdcross-sectional dimension D_(C3) can be approximately the same as thesecond cross-sectional dimension D_(C2) such that the first and secondanchoring members 610, 710 meet at a flared junction 740. In oneembodiment, the first and second anchoring members 610 and 710 can becoupled at the flared junction 740; however, in other embodiments, thefirst and second anchoring members 610 and 710 are not coupled. FIG. 59Cshows another embodiment of the device 700 wherein the downstream region615 of the first anchoring member 610 is separated from the upstreamregion 713 of the second anchoring member 710 by a gap 750. In oneembodiment, the device 700 shown in FIG. 59C can be implanted at thenative heart valve such that the first anchoring member 610 can engagesupra-annular tissue or other cardiac tissue upstream of the annulus andthe second anchoring member 710 can engage subannular tissue or othercardiac tissue downstream of the annulus such that the annulus isretained or captured within the gap 750.

In a further embodiment illustrated in FIG. 59D, the thirdcross-sectional dimension D_(C3) is greater than the secondcross-sectional dimension D_(C2) such that the second anchoring member710 can partially surround the first anchoring member 610. In such anembodiment, the downstream region 611 of the first anchoring member 610can apply radial outward pressure against an inner wall 741 of thesecond anchoring member 710 and further support the fixation of thesecond anchoring member 710 to the tissue on or under the annulus AN.

Additionally, the valve support 120 can be radially separated from thedownstream region 611 of the first anchoring member 610 as well as theupstream region 712 of the second anchoring member 710 such that whenthe device 700 is deployed, the downstream region 611 and/or theupstream region 712 can deform inwardly without substantially deformingthe valve support 120 or without deforming a support region 734 of thevalve support 120 supporting the prosthetic valve 130. Additionally, thefirst and second anchoring members 610, 710 can have a generally oval orD-shape, or other irregular shape such as those described above withrespect to FIGS. 16A-17C, while the valve support 120 can be generallycylindrical in shape. Moreover, additional features may be incorporatedon the device 700, such as sealing membranes 140 and tissue engagingelements 170 as described above with respect to the device 100.

FIGS. 60A-60B are cross-sectional side views of a distal end of adelivery catheter 18 for delivering the prosthetic heart valve device700 of FIG. 59C to a native mitral valve in the heart in accordance withanother embodiment of the present technology. As shown in FIGS. 60A-60Bthe prosthetic heart valve device 700 is collapsed into a deliveryconfiguration 706 and retained within a two portion delivery sheath 70at the distal end of the catheter 18 (FIG. 60A). Upon delivery of thedistal end of the catheter 18 to the desired location at or near anative mitral valve, the device 700 can be released from the two portionsheath 70 by retracting an upper portion 72 in a distal direction and/orretracting a lower portion 74 in a proximal direction (shown with arrowsin FIG. 60A) thereby separating the sheath and exposing the collapseddevice 700 from within the sheath 70. In one embodiment, the device 700can self-expand to its expanded configuration 702 following retractionof the sheath 70 (FIG. 60B). As illustrated in FIG. 60B, when the sheath70 is retracted in both the proximal and distal directions, the firstand second anchoring members 610, 710 can self-expand outwardly toengage the native tissue. When using a balloon 300 to expand the supportvalve 120, the balloon 300 can be inflated to fully expand the device700.

FIG. 61 illustrates a prosthetic heart valve device 800 configured inaccordance with another embodiment of the present technology. FIG. 61 isa side view of the device 800 that includes features generally similarto the features of the prosthetic heart valve devices 100, 600, 700described above with reference to FIGS. 10A-60B. For example, the device800 includes a support valve 120 having upstream and downstream ends121, 123 and an interior in which a valve (not shown) may be coupled.The device also includes first and second anchoring members 810 and 850.The first anchoring member 810 has a first flared upstream portion 812and a first downstream portion 811 that is coupled to an outer orexterior surface 127 of the valve support 120. The first flared upstreamportion 812 can be mechanically isolated from the valve support 120.Additionally, the first flared upstream portion 812 can be configured toengage supra-annular tissue of the native mitral valve. The secondanchoring member 850 can be configured to at least partially surroundthe first anchoring member 810 and to have a second flared upstreamportion 852 for engaging the subannular tissue of the native mitralvalve. The second anchoring member 850 can also have a second downstreamportion 851 coupled to the outer surface 127 of the valve support 120 ina manner that mechanically isolates the valve support 120 from at leastthe second upstream portion 852.

As shown in FIG. 61, the first anchoring member 810 can have a pluralityof first longitudinal ribs 814 and the second anchoring member 850 canhave a plurality of second longitudinal ribs 854. In one embodiment,each of the individual first ribs 814 are longer than each of theindividual second ribs 854 such that the first anchoring member 810 hasa height H_(AM1) greater than a height H_(AM2) of the second anchoringmember 850. Accordingly, the height H_(AM2) can be selected to orientthe second anchoring member 850 to engage subannular tissue, while theheight H_(AM1) can be selected to orient the first anchoring member 810to extend through the mitral valve from the left ventricle to engagesupra-annular tissue in the left atrium.

FIG. 61 illustrates one embodiment of the device 800 that can include alower ring 808 on which the ribs 814, 854 can be interconnected. Thelower ring 808 can allow the ribs 814, 854 to expand radially outwardaway from the valve support 120 at the upstream portions 812, 852. Thedevice 800 can also include a first upper ring member 816 coupled to theplurality of first longitudinal ribs 814. The first upper ring member816 can be shaped and or patterned to have a downward oriented rim 818for engaging supra-annular tissue. The device can further include asecond upper ring member 856 coupled to the plurality of secondlongitudinal ribs 854. The second upper ring member 856 can be shapedand or patterned to have an upward oriented rim 858 for engagingsubannular tissue.

FIGS. 62A-62C are partial cross-sectional side views of a distal end ofa delivery system 10 showing delivery of the prosthetic heart valvedevice 800 of FIG. 61 at a mitral valve MV in accordance with anotherembodiment of the present technology. The device 800 can be retained ina collapsed configuration 806 within a sheath 20 of the delivery system(FIG. 62A). When the distal end of the delivery system engages thetarget location, the sheath 20 can be retracted proximally from thedevice 800, thereby releasing the features of the device 800 to expandinto the expanded configuration 102 (FIGS. 62B-62C). As shown in FIG.62B, the second anchoring member 850 can be released first from theretracting sheath 20 and the upward oriented rim 858 of the second upperring member 856 can be positioned to engage the subannular tissue. Thesheath 20 can prevent the first anchoring member 810 from disengagingfrom the delivery system 10 and/or moving outside the sheath 20 untilthe rim 858 of the second anchoring member 850 is moved into position toengage the subannular tissue. Referring to FIG. 62C, a plunger 11 canengage the first anchoring member 810 (as shown by downward arrow inFIG. 62B) and/or the sheath 20 can be disengaged/retracted (shown byupward arrow in FIG. 62C) from the first anchoring member 810 therebyallowing the second anchoring member 850 to move radially outward to theexpanded configuration 802. The downward oriented rim 818 of the firstupper ring member 816 can be positioned to engage the supra-annulartissue (FIG. 62C). Once deployed, the rings 816, 856 can sandwich theannulus AN of the mitral valve and inhibit movement of the device 800 inboth upstream and downstream directions.

FIG. 63 is an isometric side view of a prosthetic heart valve device 900in accordance with a further embodiment of the present technology. Thedevice 900 includes features generally similar to the features of theprosthetic heart valve devices 100, 600, 700 and 800 described abovewith reference to FIGS. 10A-62C. For example, the device 900 includes asupport valve 120 having upstream and downstream ends 121, 123 and aninterior in which a valve (not shown) may be coupled. The device 900includes an anchoring member 910 that has a flared upstream portion 912and a downstream portion 911 coupled to the valve support 120. However,the device 900 also includes upper and lower rings 950, 952 and aplurality of flexible annulus engaging elements 970 distributed around acircumference 980 of the anchoring member 910 and configured to couplethe upper ring 950 to the lower ring 952. The flexible annulus engagingelements 970 can have a shape such as a C-shape or U-shape that isoriented to have an open portion outward from the device 900 such thatthe native annulus AN can be engaged in recesses 971 of the annulusengaging elements 970. The annulus engaging elements 970 can alsoinclude points 972, 973 for engaging and potentially piercingsupra-annular and subannular tissue, respectively. The annulus engagingelements 970 can be suitably flexible to bend in a manner that bringsthe points 972, 973 close together for securing the device 900 to theannulus AN when the device 900 is deployed.

FIGS. 64A-64B illustrate a method for deploying the device 900 at thenative mitral valve. Referring to FIGS. 63 and 64A-64B together, theannulus engaging elements 970 can be generally relaxed or have a widerecess 971 in an open state 903. As such, the upper ring 950 can restabove the lower ring 952 a first distance D_(R1) when the elements 970are in the open state 903. The device 900 can also include a pluralityof pull-wires 974 that are slideably engaged with the upper ring 950(e.g., through holes 975) and secured to the lower ring 952. When thewires 974 are pulled in an upward or upstream direction, the lower ring952 moves in an upward/upstream direction toward the upper ring 950. Asthe lower ring 952 approaches the upper ring 950, the annulus engagingelements 970 can bend such that the points 972, 973 are brought closertogether and/or engage or pierce the annulus tissue (FIG. 64B).Accordingly, when the device 900 is in the deployed state 904, the upperring 950 can be held by the pull-wires 974 at a second distance D_(R2)above the lower ring 952, wherein the second distance D_(R2) is lessthan the first distance D_(R1).

FIGS. 64C-64D show an alternative arrangement of the pull-wires 974 inwhich the wires 974 are secured to the upper ring 950 and are slideablyengaged with the lower ring 952 (e.g., through holes 976). Thepull-wires 974 can also be slideably engaged with the upper ring 950(e.g., such as through holes 975) such that the pull-wires can be pulledin an upward direction to bring the rings 950, 952 closer together inthe deployed state 904.

FIG. 65A is an isometric side view of a prosthetic heart valve device1000 in accordance with a further embodiment of the present technology.The device 1000 includes features generally similar to the features ofthe prosthetic heart valve devices 100, 600, 700, 800 and 900 describedabove with reference to FIGS. 10A-64D. For example, the device 1000includes a support valve 120 having upstream and downstream ends 121,123 and an interior 134 in which a valve 130 may be coupled. However,the device 1000 includes an inflatable anchoring member 1010 coupled toand at least partially surrounding the valve support 120. The inflatableanchoring member 1010 can be configured to inflate/expand upondeployment and engage native tissue at the desired target location. Asshown in FIG. 65A, the inflatable anchoring member 1010 can have one ormore fillable chambers 1014 for receiving a fill substance such as asolution (e.g., saline or other liquid) or gas (e.g., helium, CO₂ orother gas) following implantation of the device 1000. In otherembodiments, the fillable chambers 1014 can be filled with a hardeningmaterial (e.g., epoxy, cement, or other resin).

In one embodiment, the fillable chambers 1014 and/or the anchoringmember 1010 can be formed of polytetrafluoroethylene (PTFE), urethane,or other expandable polymer or biocompatible material. The fillablechambers 1014 can have a predetermined shape such that the fillablechambers 1014, when inflated, form fixation elements 1015 for engagingthe native anatomy. For example, the fixation elements 1015 can includea supra-annular flange 1016 for engaging a surface of the annulus ANwithin the left atrium LA. The elements 1015 may also include subannularflanges 1018 for engaging subannular tissue and/or arms 1020 forengaging leaflets LF (e.g., behind leaflets). Accordingly, the chambers1014 can be incorporated or shaped such that the anchoring member 1010engages supra-annular tissue, subannular tissue, leaflets or othertissue at or near the mitral valve MV while mechanically isolating thevalve support 120 from distorting diastolic and systolic forcesgenerated in the heart and particularly radial forces exerted on thedevice 1000 at or near the native mitral valve. For example, followingdeployment, the inflatable anchoring member 1010 can absorb pulsatileloading and other forces generated against the device 1000 such thatdeformation of the anchoring member 1010 does not substantially deformthe valve support 120.

FIG. 65B is a partial cross-sectional side view of a distal end of adelivery system 10 suitable for delivery of the prosthetic heart valvedevice 1000 of FIG. 65A in accordance with another embodiment of thepresent technology. As shown in FIG. 65B, the delivery system 10 caninclude a delivery catheter 18 configured to retain the device 1000 in acollapsed configuration 1006. In the collapsed configuration 1006, theinflatable anchoring member 1010 is deflated. The delivery system 10 canalso include a fill tube 90 suitable to deliver the fill substance whenthe device 1000 is in position and ready for deployment. Referring toFIGS. 65A-65B together, and in one embodiment, the inflatable anchoringmember 1010 can be partially filled with the fill substance such thatthe position of the device 1000 at the implant site can be adjusted toalign the fixation elements 1015 with the native tissue features beforefully expanding and/or inflating the anchoring member 1010 to hold thedevice 1000 in place at the target location.

FIGS. 66A-66D are cross-sectional views of prosthetic heart valvedevices 1100 having fillable chambers 1114 in accordance with additionalembodiments of the present technology. Similar to the device 1000discussed with respect to FIGS. 65A-65B, the devices 1100 includefeatures such as the valve support 120 having an interior 134 in which avalve 130 is coupled and include an expandable anchoring member 1110coupled to the valve support 120 in a manner that mechanically isolatesthe valve support 120 from forces exerted upon the anchoring member 1110when implanted at the native mitral valve. The anchoring member 1110 canbe coupled to the valve support 120 such that an upstream region 1112 ofthe anchoring member 1110 is configured to engage native tissue on ordownstream of the annulus so as to prevent migration of the device 1100in the upstream direction. In the embodiments shown in FIGS. 66A-66D,the devices 1100 can also include one or more fillable chambers 1114configured to expand and/or inflate in an outward direction to supportan outward expansion of the anchoring member 1100 (FIGS. 66A, 66C-66D),or to engage native tissue (FIG. 66B). In one embodiment, the fillablechambers 1114 and/or the anchoring member 1010 can be formed ofpolytetrafluoroethylene (PTFE), urethane, or other expandable polymer orbiocompatible material. The fillable chambers 1114 can have apredetermined shape such that the fillable chambers 1114, when inflated,form fixation elements for engaging the native anatomy (as shown in FIG.66B) or for engaging the anchoring member 1110 (as shown in FIGS. 66A,66C and 66D).

Referring to FIG. 66A, the fillable chamber 1114 can be chambers 1114created with a space between the valve support 120 and the anchoringmember 1110. Following expansion of the device 1100, the fillablechambers 1114 can be filled with a fill substance such as a solution(e.g., saline or other liquid) or gas (e.g., helium, CO₂ or other gas).In other embodiments, the fillable chambers 1114 can be filled with ahardening material (e.g., epoxy, cement, or other resin). In otherembodiments, the fillable chambers 1114 can be a separate component ofthe device 1100, such a ring-shaped chamber 1150 coupled to an outersurface 1142 of the anchoring member 1110 (FIG. 66B) or to an innersurface 1141 of the anchoring member 1110 or to an exterior surface 127of the support valve 120. In FIGS. 66C-66D, for example, the ring-shapedchamber 1150 can provide additional support to the anchoring member 1110such that inward deformation is counteracted by the presence of thering-shaped chamber 1150. Additionally, as shown in FIG. 66D, thefillable chamber 114 can be a ring-shaped chamber 1150 that deforms theanchoring member 1110 in an outward direction against the native tissue.

In accordance with another aspect of the present technology, FIGS.67A-67B illustrates other embodiments of a prosthetic heart valve device1200. Referring to FIGS. 67A-67B together, the device 1200 can include aradially expandable anchoring member 1210 configured to engage nativetissue on or downstream of the annulus, and a support valve 120 and/or aprosthetic valve 130 coupled to an interior portion 1234 of theanchoring member 1210. The anchoring member 1210 can have a firstlongitudinal length L_(L1) on a posterior leaflet-facing side 1222 ofthe anchoring member 1210 and have a second longitudinal length L_(L2)on an anterior leaflet-facing side 1224 of the anchoring member 1210. Asshown in FIG. 67A, the first length L_(L1) is greater than the secondlength L_(L2) such that occlusion of a left ventricle outflow tract(LVOT) is limited. Accordingly, in one embodiment, the posteriorleaflet-facing side 1222 can provide suitable fixation and support forthe anchoring member 1210 by engaging the thicker ventricular wall andtissue on the posterior leaflet side of the mitral valve. Concurrently,the shorter anterior leaflet-facing side 1224 of the anchoring member1210 can have sufficient sealing and conformability to engage theanterior leaflet and/or subannular tissue aligned with the anteriorleaflet of the native valve.

Optionally, the device 1200 can also include one or more stabilizingelements such as an arm 1250 coupled to the anchoring member 1210 forengaging a leaflet and/or a subannular surface. In FIG. 67A, the arm1250 can be coupled to a downstream end 1223 of the anchoring member1210 on the posterior leaflet-facing side 1222 of the anchoring member1210 and be configured to extend behind the posterior leaflet. In oneembodiment, the arm 1250 can be configured to sandwich the posteriorleaflet between the arm 1250 and the anchoring member 1210.

In FIG. 67B, the device 1200 can include first and second arms(individually identified as 1250 a and 1250 b) coupled to the anchoringmember 1210 for engaging leaflets and/or subannular surfaces. Forexample, the first arm 1250 a can be coupled to the downstream end 1223at the anterior leaflet-facing side 1224 of the anchoring member 1210with extension 1251 a and can be configured to further extend behind theanterior leaflet. The second arm 1250 b can be coupled to the downstreamend 1223 of the posterior leaflet-facing side 1222 of the anchoringmember 1210 with extension 1251 b and be configured to extend behind theposterior leaflet. In the illustrated embodiment, the extensions 1251 aand 1251 b can vary with respect to each other and be selected based onthe anatomy of the target tissue. In other embodiments, not shown, thearm 1250 and or the anchoring member 1210 can include tissue engagingelements as described above with respect to device 100 for furtherpositioning and stabilizing of the device 1200 at the desired targetlocation. One of ordinary skill will recognize that the valve support120 can also be uneven or have sides having different lengths such thatthe valve support will not substantially occlude the left ventricleoutflow tract (LVOT).

FIGS. 68A-68B are side views of prosthetic heart valve devices 1300shown in an expanded configuration 1302 and configured in accordancewith an additional embodiment of the present technology. The prostheticheart valve devices 1300 include features generally similar to thefeatures of the prosthetic heart valve device 100 described above withreference to FIGS. 10A-56. For example, the prosthetic heart valvedevice 1300 includes the valve support 120 configured to support aprosthetic valve 130 and an anchoring member 110 coupled to the valvesupport 120 in a manner that mechanically isolates the valve support 120from forces exerted upon the anchoring member 110 when implanted at thenative mitral valve. However, in the embodiments shown in FIGS. 68A-68B,the device 1300 also includes a positioning element 1350 configured toadjust or maintain a desired position of the device 1300 within or nearthe native mitral valve (e.g., away from the LVOT). The positioningelement 1350 can be coupled to the downstream portion 111 of theanchoring member 110 (as shown in FIGS. 68A-68B), the upstream portion112 of the anchoring member 110, or to the valve support 120, at anelement connection point 1352 and extend outward from the elementconnection point 1352 to engage ventricular tissue at a desiredlocation. In one embodiment, the positioning element 1350 can extendoutward from the device 1300 in a direction approximately transverse tothe longitudinal axis 101. In other embodiments, not shown, thepositioning element 1350 can extend outwardly from the device 1300 at anobtuse or an acute angle relative to the longitudinal axis 101 forengaging the ventricular tissue at the desired location.

In the embodiment shown in FIG. 68A, the positioning element 1350 caninclude a positioning arm 1354 and a tissue engaging portion 1356coupled to the distal arm end 1358 of the positioning arm 1354. Thepositioning arm 1354 and tissue engaging portion 1356 together canextend a desired positioning distance D_(P1) away from the elementconnection point 1352 on the device 1300 (e.g., from the anchoringmember 110) such that the distal end 1360 of the positioning element1350 can engage ventricular tissue, such as a ventricular wall. In someembodiments, the positioning distance D_(P1) can be selected to begreater than a distance between the implanted device 1300 and theventricular tissue such that the positioning element 1350, afterengaging the ventricular tissue, extends the distance between theimplant device 1300 and the ventricular tissue. In this way, the device1300 can be positioned, aligned and maintained in an alternate positionwithin or near the mitral valve.

The tissue engaging portion 1356 can be configured to contact theventricular tissue, or other tissue (e.g., annular tissue, leaflettissue, etc.), in an atraumatic manner such that the tissue engagingportion 1356 does not penetrate or pierce the tissue. In one embodiment,the tissue engaging portion 1356 can be resilient and/or be formed of ashape memory material (e.g., Nitinol) that can be partially deformedwhen engaging tissue. For example, the tissue engaging portion 1356 canbe configured to absorb forces generated by the ventricular tissue(e.g., ventricular wall) during e.g., systole, without translatingmovement or altering a desired position of the device 1300 with respectto the native mitral valve. In other embodiments, the distal end 1360 ofthe positioning element 1350 can have other shapes or configurationsthat penetrate the ventricular tissue. The device 1300 can include oneor more positioning elements 1350 disposed around the device 1300 forpositioning and/or maintaining a desired position of the device 1300with respect to native anatomy. For example, it may be desirable toincrease the distance between the device 1300 and the left ventricularoutflow tract (LVOT), and a positioning element 1350 can be configuredto engage ventricular tissue to push or encourage the device 1300 aselected distance away from the LVOT.

In the embodiment shown in FIG. 68B, the positioning element 1350 caninclude a looped tissue engaging portion 1358 coupled to the device 1300at the connection point 1352. The looped tissue engaging portion 1358can extend the desired positioning distance D_(P1) away from the elementconnection point 1352 on the device 1300 (e.g., from the anchoringmember 110) such that the distal end 1360 of the looped tissue engagingportion 1358 can engage ventricular tissue, such as a ventricular wall.The looped tissue engaging portion 1358 can be configured to absorbradially contracting forces or other forces generated and transmitted bythe ventricular tissue (e.g., within the left ventricle) such that theyare not transmitted to or can change the position of the device 1300with respect to the native heart valve. Accordingly, the device 1300 canbe positioned, aligned and maintained in an alternate position within ornear the mitral valve.

In another embodiment, not shown, a positioning structure, separate fromthe prosthetic heart valve device 100, can be implanted or otherwisepositioned in the left ventricle (e.g., at or near the LVOT) and whichcan be configured to engage portions of the device 100, such as theanchoring member 110. Accordingly, such a positioning structure can beprovided to prevent the device 100 from obstructing or partiallyobstructing the LVOT. In one embodiment, not shown, the positioningstructure could be a stent-like cylinder or cage that expands intoengagement with the ventricular wall and keeps the LVOT clear to allowblood to flow freely from the left ventricle through the aortic valve.In one example, the positioning structure could be delivered by catheterthat is inserted through the aorta and the aortic valve into the leftventricle, or through the apex or the left atrium via the same deliverycatheter used for delivering and implanting the device 100.

FIGS. 69A-69E are cross-sectional and side views of prosthetic heartvalve devices 1400 shown in an expanded configuration 1402 andconfigured in accordance with an additional embodiment of the presenttechnology. The prosthetic heart valve devices 1400 include featuresgenerally similar to the features of the prosthetic heart valve devices100, 600 described above with reference to FIGS. 10A-57E. For example,the prosthetic heart valve devices 1400 include the valve support 120configured to support a prosthetic valve 130 and an anchoring member 110or 610 coupled to the valve support 120 in a manner that mechanicallyisolates the valve support 120 from forces exerted upon the anchoringmember 110 when implanted at the native mitral valve. However, in theembodiments shown in FIGS. 69A-69E, the devices 1400 also includes a anexpandable tissue-engaging ring 1450 coupled to a tissue engagingportion of the anchoring member 110 and configured to provide additionalcontact surface for engaging native tissue at or near the annulus of theheart valve.

In one embodiment, shown in FIGS. 69A-69B, the expandabletissue-engaging ring 1450 can be coupled to an upstream perimeter 113 ofthe anchoring member 110 and have a tissue-engaging surface 1452 facingin an outward direction relative to the device 1400. In someembodiments, the tissue-engaging surface 1452 can have tissue-engagingelements 170 for engaging and/or piercing the tissue. In anotherembodiment, shown in FIG. 69C, the expandable tissue-engaging ring 1450can be coupled to a downstream perimeter 115 of the anchoring member1410 and have a tissue-engaging surface 1452 facing in an outwarddirection relative to the device 1400. In another embodiment shown inFIG. 69D, the expandable tissue-engaging ring 1450 may include aplurality of fibrous elements 1454 (e.g., fiber elements) that can beconfigured to encourage tissue ingrowth, thrombus and/or be configuredto provide a seal between the anchoring member 110 and the tissue. Invarious arrangements, the expandable tissue-engaging ring 1450 canexpand and contract between various deployment and deliveryconfigurations.

FIG. 69E shows another embodiment of the prosthetic heart valve device1400 having the expandable tissue-engaging ring 1450. In thisembodiment, the device 1400 can have a valve support 120 coupled to afirst anchoring member 110 and a second anchoring member. In oneembodiment, the first anchoring member 110 can be coupled to the valvesupport 120 at the downstream end 123 and extends outward and in anupstream direction. The second anchoring member 1410 can be coupled tothe valve support 120 at the upstream end 121 and extend outward and ina downstream direction. The expandable tissue-engaging ring 1450 can becoupled to the distal portions of the first and second anchoring members110, 1410 and have the tissue-engaging surface 1452 facing in an outwarddirection relative to the device 1500 for engaging tissue at or near theannulus AN or leaflets LF. In a particular example, the expandabletissue-engaging ring 1450 can have a first end 1460 coupled to anupstream end 1461 of the first anchoring member 110. The expandabletissue-engaging ring 1450 can also have a second end 1470 coupled to adownstream end 1471 of the second anchoring member 1410. Thetissue-engaging surface 1452 may also include tissue engaging elements170 for engaging and/or piercing the tissue at the target location.

Referring to FIGS. 69A-69E together, the outward radial force of theexpandable tissue-engaging ring 1450 against the tissue and supported bythe anchoring members 110 and/or 1410 can prevent the device 1400 frommigrating in an upstream direction. Additionally, the expandabletissue-engaging ring 1450 along with at least the portions of theanchoring members 110 and/or 1410 that are uncoupled from the valvesupport 120 can effectively mechanically isolate the valve support 120and the valve 130 from compromising radially compressive forces exertedon the device 1400 from the heart valve tissue.

FIG. 70 is a cross-sectional side view of another prosthetic heart valvedevice 1500 configured in accordance with an embodiment of the presenttechnology. The device 1500 can also include features as described aboveincluding a valve support 120 and a prosthetic valve 130 retained withinthe valve support 120. The device 1500 can also include a plurality ofanchoring members (individually identified as 110 a-c). The anchoringmembers 110 a-c can be coupled at respective downstream perimeters 115a-c to the valve support 120 and be separated by gaps 1515 such thatrespective upstream perimeter 113 a-c can engage cardiac tissue atvariable target locations at the native valve. Optionally, the device1500 can also include the expandable tissue-engaging ring 1450 (FIGS.69A-D) such as those having tissue engaging features 170 for furtherengaging tissue at the native valve. In one embodiment, the expandabletissue-engaging ring 1450 can be coupled to the upstream perimeter ofmore than one anchoring member (e.g., the upstream perimeters 113 b and113 c of anchoring members 110 b and 110 c). However, in otherarrangements, the device 1500 will not have the expandabletissue-engaging ring 1450.

FIG. 71 is a cross-sectional side view of yet another prosthetic heartvalve device 1600 configured in accordance with an embodiment of thepresent technology. The device 1600 can also include features asdescribed above including a valve support 120 and a prosthetic valve 130retained within the valve support 120. The device 1500 can also includethe anchoring member 110. However, the device 1600 can also include anexpandable retainer 1610 for further engaging tissue at or near thenative valve annulus. In one embodiment, the retainer 1610 can be anextension of upstream end 121 of the valve support 120, however, inanother embodiment, the retainer 1610 can include a separate expandablefeature coupled to the upstream end 121 of the valve support. In somearrangements, the retainer 1610 can be mechanically isolated from thevalve support 120 such that forces generated at the native valve areabsorbed or otherwise translated by the retainer 1610. In this manner,the retainer 1610 may be deformed by radial forces exerted on theretainer 1610 while the valve support remains substantially undeformed.

In one embodiment, as shown, the anchoring member 110 can be configuredto engage the retainer 1610; however, in other embodiments, theanchoring member 110 can be positioned differently such that theanchoring member 110 contacts tissue different than that of the retainer1610. For example, the anchoring member 110 may extend outside a radius(not shown) of the retainer to contact subannular tissue. Additionaldetails and embodiments regarding the structure, delivery and attachmentof retainers 1610 suitable for use with the prosthetic heart valvedevices disclosed herein can be found in International PCT PatentApplication No. PCT/US2012/61215, entitled “DEVICES, SYSTEMS AND METHODSFOR HEART VALVE REPLACEMENT,” filed Oct. 19, 2012, the entire contentsof which are incorporated herein by reference.

FIG. 72 is an isometric view of a prosthetic heart valve device 1700 inaccordance with another embodiment of the present technology. The device1700 can include an anchoring member 110, a valve support 120 positionedradially within at least a portion of the anchoring member 110, and aprosthetic valve 130 retained within the valve support 120. The device1700 can further include a first sealing member portion 140 a coupled toan inner wall of the anchoring member 110 and a second sealing memberportion 140 b coupled to the inner wall of the valve support 120. Inother embodiments, the first sealing member portion 140 a can be coupledto the outer wall of the anchoring member 110 and/or the second sealingmember portion 140 b can be coupled to the outer wall of the valvesupport 120. The first and second sealing member portions 140 a and 140b can be integral portions of a single sealing member, or the first andsecond sealing member portions 140 a and 140 b can be separate sealingmembers that are attached independently to the anchoring member 110 andthe valve support 120. The first and second sealing member portions 140a and 140 b will in any event together form a sealed barrier between thevalve support 120 and the anchoring member 110 to inhibit or preventblood from flowing outside of the valve support 120 as blood flows fromthe atrium to ventricle or vice versa. As with several embodimentsdescribed above, an upstream portion 121 of the valve support 120 isspaced radially inward from the anchoring member 110, and a downstreamportion 123 of the valve support 120 is coupled to the anchoring member110.

FIG. 73 is a side view of the prosthetic heart valve device 1700, andFIG. 74 is a bottom isometric view of the prosthetic heart valve device1700. The anchoring member 110 can include a fixation portion 1710configured to securely fix the anchoring member 110 to tissue at anative heart valve, an integration region 1720 configured to integratethe anchoring member 110 with the valve support 120, and a lateralportion 1730 between the fixation portion 1710 and the integrationregion 1720. The fixation portion 1710, integration region 1720, andlateral portion 1730 can be formed by a plurality of structural elements1711 that can extend from the fixation portion 1710 to the integrationregion 1720. The integration region 1720 and the lateral region 1730 cancollectively or individually define a connection structure thatpositions and controls the fixation portion 1710 relative to the valvesupport 120. The structural elements 1711 can be shaped and connected toform diamond-shaped or other structural configurations that provide thedesired strength and flexion. The structural elements 1711 can be strutsor other structural features formed from metal, polymers, or othersuitable materials that can self-expand or be expanded by a balloon orother mechanical expander.

Several embodiments of the fixation portion 1710 can be a generallycylindrical fixation ring having an outwardly facing engagement surface1712, which may be a large, generally cylindrical surface for engagingtissue at or near the annulus of a native valve. For example, the outersurface of the fixation portion 1710 can extend in a direction P-P thatis at least substantially parallel to a longitudinal axis L-L, or thefixation portion 1710 can be inclined to converge from the lateralportion 1730 toward the longitudinal axis L-L such that all or a portionof the fixation ring is tapered in the upstream direction. For example,the fixation portion 1710 can be inclined inwardly (arrow I) toward thelongitudinal axis L-L in the upstream direction at an angle of 0 to −30°relative to the longitudinal axis L-L. In other embodiments, thefixation portion 1710 can be inclined outwardly (arrow O) from thelongitudinal axis L-L by an angle of 0 to 45° to increase the outwardradial force. In several embodiments, the fixation portion 1710 can beparallel to an outwardly facing surface of the valve support 120.

Several embodiments of the anchoring member 110 are configured to pressthe engagement surface 1712 against tissue at an implant site on orbelow a native annulus of the native heart valve when the orientation ofthe fixation portion 1710 is at least generally parallel to thelongitudinal axis L-L or tapered inwardly in the upstream direction. Thefixation portion 1710 may have such a configuration in an unbiased statebefore implantation, or it may assume this inwardly taperedconfiguration through deformation imposed by engagement with tissue atthe implant site. For example, the fixation portion 1710 can bedeflectable through a range of angles relative to the longitudinal axisL-L such that upon engagement with the tissue the fixation portion 1710moves from an unbiased state to the implanted orientation in which it isorientated at least substantially parallel to or tapered in the upstreamdirection toward the longitudinal axis L-L. As explained in more detailbelow, the large, generally cylindrical area of the outer surface of thefixation portion 1710 and the orientation of the fixation portion 1710in a direction P-P provide good fixation to the annulus and subannulartissue of a native mitral valve or other heart valve. In severalembodiments, the fixation portion can have a height (H_(f)) of 10 mm-20mm.

The fixation portion 1710 of the anchoring member 110 may have differentregions of radial stiffness along the P-P axis. These regions canconform to and exert an outward radial force on the surrounding anatomyto provide fixation and sealing. In one example, the radial stiffnessmay be greater in the region of the fixation portion that is downstreamof the annulus and lesser in the region that is in contact with andupstream of the annulus. This combination would provide a regiondownstream of the annulus that resists compression and ensures that thedevice maintains its fixation with respect to the anatomy when subjectedto a systolic pressure gradient and a region at the annulus that allowssome compression (preventing dilation of the annulus), but maintainssufficient radial outward force to keep the fixation portion in contactwith the anatomy to provide sealing between the device and the anatomy.

Radial stiffness may be controlled by the design of the structuralelements of the attachment portion 1720 and/or the lateral portion 1730,the taper angle or curve between these regions and the fixation portion1710, or a combination of those properties. The design of the structuralelements 1711 of the fixation portion 1710 may have different properties(wall thickness, width, length, angle, etc.) along with the P-P axis toprovide regions of different radial stiffness. Additionally, thefixation portion 1710 can have a first flexibility and the integrationregion 1720 and/or the lateral portion 1730 can have a secondflexibility different than the first flexibility. The fixation portion1710 can itself have a downstream region with a first flexibility and anupstream region with a second flexibility different than the firstflexibility.

The fixation portion 1710 can further include a plurality of tissueengaging elements 170 configured to penetrate into the annulus and/orsubannular tissue. The prosthetic heart valve device is preferablyanchored solely by the engagement of fixation portion 1710 with thenative tissue, which resists the high forces of blood against the deviceduring ventricular systole. Other means of anchoring, such astissue-engaging arms or tethers coupled to the native tissue, are notrequired. Thus, the tissue engaging elements 170 are configured toengage the native tissue to reliably resist movement of the devicewithout fully penetrating or perforating the leaflets or heart walltissue, or otherwise causing undue trauma as the heart beats. Becausethe upstream forces during ventricular systole are so high, the tissueengaging elements 170 will preferably project at least in the upstreamdirection to inhibit movement of anchoring member 110 in the upstreamdirection relative to the native tissue. Smaller forces are exerted onthe device in the downstream direction during diastole, so in some casesdownstream-projecting tissue engaging elements may also be desirable(e.g., project superiorly in the case of a mitral valve). In oneembodiment, the fixation portion 1710 can include an upper row 171 a oftissue engaging elements that project superiorly and inferiorly, asecond row 171 b of tissue engaging elements that also extend superiorlyand inferiorly, and a third row 171 c of tissue engaging elements thatextend superiorly. The tissue engaging elements 170 can be barbs, tines,pins, or other elements that penetrate into or otherwise grip the tissueof the native annulus and/or native subannular tissue. In severalembodiments, the tissue engaging elements 170 project radially outwardfrom the structural elements 1711 of the fixation portion 1710 by adistance of approximately 0.5-5 millimeters.

The integration region 1720 of the anchoring member 110 can be formedfrom the lower portions of the structural elements 1711. In theembodiment illustrated in FIGS. 73 and 74, the integration region 1720has a plurality of diamond-shaped structures 1722 and vertical members1724. In the illustrated embodiment, each of the vertical members 1724can include a portion of two of the structural elements 1711. In severalembodiments, the anchoring member 110 and the valve support 120 are madefrom separate struts, and the integration region 1720 is an attachmentportion or fastening portion of the anchoring member 110 that isattached to the valve support 120. For example, when the anchoringmember 110 and the valve support 120 are separate components, theintegration region 1720 can be an attachment portion including aplurality of connecting points 1726 where the integration region 1720 iscoupled to the valve support 120. In one embodiment, the integrationregion 1720 of the anchoring member 110 can be connected to the valvesupport 120 at a plurality of connecting points 1726 (e.g., 12) usingNitinol rivets. In other embodiments, threads, adhesives, solder, laserwelding, metal bolts or other mechanical features, or other types offasteners can be used to secure the valve support 120 to the integrationregion 1720. The integration region 1720 can thus be a fasteningportion.

In other embodiments, the anchoring member 110 and the valve support 120are integrally formed together from common struts, or a number of strutscan be integrally formed with both the anchoring member 110 and thevalve support 120. In these embodiments, the integration region 1720 isthe structure that transitions from the anchoring member 110 to thevalve support 120 without otherwise being fastened together. Forexample, the integration region 1720 can be a curved or otherwise bentportion of such struts between a cylindrically shaped valve support 120and the portion of the anchoring member 110 that projects away from thevalve support 120.

The lateral portion 1730 extends between the upper region of theintegration region 1720 and the lower region of the fixation portion1710 in the embodiment shown in FIGS. 72-74. The lateral portion 1730,for example, extends laterally outward from the integration region 1720to the fixation portion 1710. In one embodiment, the lateral portion1720 includes a plurality of connectors 1732 having lateral sections1733 (FIG. 74) formed from a portion of the structural elements 1711.The lateral sections 1733 of the connectors 1732 extend laterally, whichin several embodiments is a direction transverse to the longitudinalaxis L-L in an outwardly straight, conical, curved, or outwardly angled(e.g., flared) configuration. Additionally, “traverse direction”includes any non-parallel direction relative to the longitudinal axisL-L. The connectors 1732 can have a first transition zone 1734 thatcurves from the orientation of the fixation portion 1710, which isgenerally parallel to or canted inwardly toward the longitudinal axisL-L, to the lateral sections 1733 of the connectors 1732 that aretransverse to the longitudinal axis L-L. In many embodiments the lateralsections 1733 of the connectors 1732 are nearly perpendicular orperpendicular to the longitudinal axis L-L. The connectors 1732 can alsohave second transition zone 1736 that curves from the lateral sections1733 of the connectors 1732 to the orientation of the integration region1720 that extends at least generally parallel to the longitudinal axisL-L (FIG. 73). In the embodiment shown in FIG. 73, the first transitionzone 1734 is an inward and/or superior bend at an angle of approximately60°-160° (e.g., approximately 90°) from the lateral sections 1733 to theorientation of the engagement surface 1712 of the fixation portion 1710.The second transitional zone 1736 can be a downward and/or inferior bendat an angle in the range of 75°-160° (e.g., approximately 90°) from thelateral sections 1733 of the connectors 1732 to the integration region1720. The smaller angles result in an S-Shape; the larger angles resultin a tapered transition as shown in FIG. 75. The first transition zone1734 can thus be a concave curve with respect to the longitudinal axisL-L, and similarly the second transition zone 1736 can be a convex curvewith respect to the longitudinal axis L-L. The curves of the firsttransition zone 1734 and the second transitional zone 1736 enable thefixation portion 1710 to present a large engagement surface 1712 tocontact the annulus and leaflets of the native heart valve to providegood fixation of the device 1700. The connectors 1732 also enable thefixation portion 1710 to flex based on the shape of the native annulusand the contraction of the left ventricle without transmitting the fullforces of such flexure of the fixation portion 1710 to the upstreamportion 121 of the valve support 120 where the prosthetic valve 130 isattached. The device 1700 accordingly provides enhanced fixation to thenative tissue and sufficient mechanical isolation between the fixationportion 1710 and the upstream portion 121 of the valve support 120 suchthat the prosthetic leaves of the prosthetic valve 130 maintainsufficient contact with each other to inhibit backflow after theanchoring member 110 has been implanted at a native mitral valve andduring left ventricular contraction.

In several embodiments, as explained above, the integration region 1720and the lateral portion 1730 can individually or collectively define aconnecting structure that interconnects the anchoring member 110 andvalve support 120. The connecting structure can comprise a plurality ofstruts that each have an inner end connected to or integral with thevalve support 120 and an outer end connected to or integral with theanchoring member 110. For example, the connecting structure can be aflared portion that flares outwardly from the valve support 120 in theupstream direction, and in selected embodiments the connecting structurecan be configured to be disposed entirely downstream of the nativeannulus when the anchoring member is at the implant site. The connectingstructure can have an upstream end connected to the anchoring membersuch that the upstream end is positioned below the native annulus whenthe anchoring member is at the implant site.

The anchoring member 110 can thus include the fixation portion 1710 andthe connection structure 1720/1730, and the connection structure1720/1730 can have an inner end connected to the valve support 120, anouter end connected to the fixation portion 1710, and an intermediateportion between the inner end and the outer end which flares outwardlyfrom the valve support 120. The intermediate portion, for example, canflare outwardly in an upstream direction.

The fixation portion 1710 can have a skirt covering an inward-facingsurface of the fixation portion 1710, and in additional embodiments theskirt can further cover an inward-facing side of the connectingstructure. Additionally, the device 1700 can further include a tubularvalve cover extending around the valve support, and the skirt can beattached to the tubular valve cover. In additional embodiments, thevalve cover is disposed on an inward facing surface of the valvesupport.

FIG. 75 is a side view of another embodiment of the prosthetic heartvalve device 1700, and FIG. 76 is a bottom view of the prosthetic heartvalve device 1700 shown in FIG. 75. In this embodiment, the connectors1732 of the lateral portion 1730 are defined by laterally extendingportions of individual structural elements 1711 that extend between thefixation portion 1710 and the integration region 1720. Referring to FIG.76, each connector 1732 includes a single one of the structural elements1711 as opposed to two structural elements 1711 as shown in FIGS. 72-74.Additionally, the connectors 1732 are inclined at a non-perpendicularangle with respect to the longitudinal axis L-L of the device 1700. Theconnectors 1732 nonetheless each include a first transition 1734 bendingfrom the connectors 1732 to the fixation portion 1710, and a secondtransition zone 1736 bending from the connectors 1732 to the integrationregion 1720.

FIG. 77 is a side view of the prosthetic heart valve device 1700 inaccordance with another embodiment of the present technology. In thisembodiment, the device 1700 wraps a portion of the first sealing memberportion 140 a around a rim 1714 of the fixation portion 1710 of theanchoring member 110. The section of the first sealing portion 140 awrapped over the rim 1714 provides an atraumatic edge to protect theroof of the left atrium during implantation and use.

FIG. 78 is an isometric view of the prosthetic heart valve device 1700in accordance with yet another embodiment of the present technology. Inthis embodiment, the material of the second sealing portion 140 b on theinside of the valve stent 120 has openings 142 a-142 c spaced apart fromeach other around the perimeter of the valve support 120. The openings142 a-142 c are spaced between the commissures where the prostheticvalve 130 is attached to the second sealing portion 140 b. In operation,the open areas 142 a-142 c are expected to decrease static blood volumeon the atrial side of the device 1700 to reduce fibrin and thrombusdeposition and to provide better flow dynamics.

FIGS. 79A and 79B are partial cross-sectional views of a heart (H) andside views of an embodiment of the prosthetic heart valve device 1700showing an embodiment of a method for implanting the prosthetic heartvalve device 1700 in accordance with the present technology. Referringto FIG. 79A, the device 1700 is attached to a delivery device 1800(shown schematically) and inserted into the heart (H) via a transapicalapproach in a low-profile configuration (not shown). The device 1700 isinserted superiorly (arrow S) through the native mitral valve (MV). Thefixation portion 1710 of the device 1700 can be positioned in the leftatrium (LA) at this stage of the procedure, and then relative movementbetween an outer member 1810 and an inner member 1820 of the deliverydevice 1800 can release the fixation portion 1710 from the deliverydevice 1800. The fixation portion 1710 can then self-expand or beexpanded using a balloon or other mechanical expander to a partiallydeployed state in which the integration region 1720 remains attached tothe delivery device 1800. In the partially deployed state shown in FIG.79A, the fixation portion can have a diameter that is larger than theopening defined by the annulus (AN) of the mitral valve (MV). Inselected embodiments, the outer diameter of the fixation portion 1710 ofthe device 1700 can be between approximately 38 mm and 56 mm dependingon the size and shape of the native annulus (AN) of the mitral valve(MV). It will be appreciated that other sizes can be used depending onthe specific anatomy of a patient.

FIG. 79B illustrates the prosthetic heart valve device 1700 after it hasbeen positioned at a desired location with respect to the annulus (AN)of the native mitral valve (MV). The device 1700 reaches the positionshown in FIG. 79B by moving the delivery device 1800 (FIG. 79A)inferiorly (arrow W) until the fixation portion 1710 contacts andfixedly engages the annulus (AN). In some embodiments, the rim 1714 ofthe fixation portion 1710 can project slightly superior of the annulus(AN). The rim 1714 can accordingly be positioned approximately 1-5 mmabove the native annulus (AN) at the anterior leaflet (AL) side of theatrium (LA) in such embodiments. In other embodiments, the rim 1714 ofthe fixation portion 1710 can be positioned at or below the upper rim ofthe annulus (AN) such that the fixation portion 1710 contacts at leastthe annulus (AN) and potentially a portion of the anterior leaflet (AL)and/or the posterior leaflet (PL) of the mitral valve (ML). In stillother embodiments, the rim 1714 of the fixation portion 1710 can bepositioned at a subannular (SA) location underneath the annulus (AN)(not shown in FIG. 79B). After the device 1700 is positioned at adesired location relative to the annulus (AN) of the mitral valve (MV),the delivery device 1800 (FIG. 79A) is withdrawn inferiorly (arrow W inFIG. 79A) and removed from the patient.

In the embodiment shown in FIG. 79B, the device 1700 is implanted suchthat the rim 1714 is approximately 1-5 mm above the native annulus (AN).Since the diameter of the fixation portion 1710 in the expandedconfiguration is greater than that of the native annulus (AN), the outersurface of the fixation portion 1710 and the tissue engaging members 170securely hold the anchoring member 110 with respect to the mitral valve(MV).

FIG. 79C is an anatomical cross-section view of a heart (H) showing thedevice 1700 implanted at a location slightly lower than the positionshown in FIG. 79B such that the rim 1714 of the fixation portion 1710pushes outward under a portion (AN1) of the native annulus (AN). Thedevice 1700 can also be implanted lower than the elevation shown in FIG.79C. For example, the rim 1714 of the fixation portion 1710 can bepositioned at an elevation E-E at the bottom of the annulus (AN) or evenat the subannular space (SA). In all of these embodiments, the portionof the native annulus (AN) over the rim 1714 further restricts thedevice 1700 from moving upwardly into the left atrium (LA) duringventricular systole.

FIG. 79D is a schematic view showing an aspect of implanting the device1700 as shown above in FIG. 79B or 79C, or in many other applications aswell. Referring to FIG. 79D, the outwardly-projecting portion of theanchoring member 110 that extends from the valve support 120 to thefixation portion 1710, which can be the laterally curved connectionstructure 1730 a in FIG. 79D, is preferably located entirely downstreamof the native annulus (AN) as shown in FIGS. 79B and 79C. For example,the transition zone 1734 between the connecting structure 1730 a and thefixation portion 1710 can be located inferiorly of the lower portion(LMV) of the mitral valve annulus (AN) to urge or drive the downstreamend of fixation portion 1710 outwardly below the annulus (AN). Thisallows the anchoring member 110 to engage tissue on the downstreamsurface of the native annulus so that that upstream forces against theprosthetic device 1700 during ventricular systole are resisted by boththe resulting upward force against the annulus (AN) as well as theoutward pressure of the fixation portion 1710 against the annulus (AN),friction between the fixation portion 1710 and the annulus (AN), and theengagement of tissue engaging elements 170 with the native tissue.

The anchoring member 110 and the valve support 120 can be configuredsuch that the downstream end of the valve support 120 is disposed notmore than 26 mm downstream of the native annulus (AN). Additionally, thefixation portion 1710 can be configured such that the engagement surfacehas a width (e.g., height) of at least about 10-20 mm. The connectingstructure can additionally have a height (H_(i) in FIG. 73) of not morethan about 0-15 mm downstream from the end at the valve support 120 tothe outer end at the fixation portion 1710. The total height (H_(t) FIG.73) of the device 1700 can be approximately 16-26 mm.

The large contact area of the engagement surface 1712 (FIG. 73) thatfaces the tissue located at or near the annulus (AN) providesexceptionally good fixation to hold the device 1700 at a desiredlocation, and the tissue engaging elements 170 around the fixationportion 1710 further enhance the fixation of the device 1700 to theregion of the annulus (AN). The transverse orientation of the connectors1732 further provides significant outward support of the fixationportion 1710 to exert a sufficient outward force against the annulus(AN), yet the orientation and configuration of the connectors 1732 incombination with attaching the valve support (not shown in FIG. 79B) tothe terminus of the integration region 1720 isolates the upstreamportion of the valve support from forces exerted by the fixation portion1710 to accommodate for the irregular shapes and motion of the mitralvalve (MV) after implantation. Also, as noted above, the anchoringmember further secures the device 1700 to the anatomy by compressingupwardly against the bottom or lower portion of the native annulus (AN)in combination with the friction and radial hoop force exerted by thefixation portion 1710 and the tissue engaging elements as describedabove with reference to FIGS. 79B-79D. Tests of the device 1700 furthershow that tissue grows in and around the fixation portion 1710, whichfurther secures the device 1700 to the desired location relative to theannulus (AN).

FIGS. 80A-80P are schematic cross-sectional views and FIG. 80Q is anisometric view of several additional embodiments of prosthetic heartvalve devices 1700 in accordance with the present technology. Likereference numbers refer to similar or identical components in FIGS.72-80Q. The embodiment of the device 1700 illustrated in FIG. 80Arepresents several of the embodiments described above with reference toFIGS. 72-79D. In this embodiment, the connectors 1732 extend at an angleα of 30°-90° with respect to the longitudinal dimension L-L of thedevice 1700. As the angle α approaches 90 degrees, the loads from thefixation portion 1710 to the valve support 120 increase relative toangles that are less than 90 degrees. As such, a greater taper (e.g.,lower angle α) reduces the loads transmitted to the valve support 120and the prosthetic valve 130.

FIG. 80B illustrates an embodiment of the device 1700 in which theconnectors 1732 have an S-shape. One advantage of having S-shapedconnectors 1732 is that the valve support 120 can be shortened tomitigate the extent that the device 1700 protrudes into the leftventricle and interrupts flow through the LVOT. As noted above, thelower end of the device 1700 can interfere with the flow through theLVOT during ventricular contraction.

FIG. 80C illustrates an embodiment of the device 1700 in which theanchoring member 110 is inverted such that the fixation portion 1710 islocated around the downstream portion 123 of the valve support 120 andthe integration region 1720 is attached to the upstream portion 121 ofthe valve support 120. This embodiment of the device 1700 positions thevalve support 120 further into the left atrium as opposed to the leftventricle.

FIG. 80D illustrates an embodiment of the device 1700 in which thefixation portion 1710 is orientated downwardly to be positioned at theelevation of the downstream portion of the valve support 1720. Thisembodiment is expected to inhibit loads from being transmitted from thefixation portion 1710 to the valve support 120, and it also positionsthe valve support 120 to reduce the valve support 120 from protrudinginto the left ventricle.

FIG. 80E illustrates an embodiment of the device 1700 in which the valvesupport 120 is offset relative to different areas of the fixationportion 1710. In this device, the anchoring member 110 can include firstconnectors 1732 a between the fixation portion 1710 and the valvesupport 120 at one side of the device 1700, and second connectors 1732 bbetween the valve support 120 and the fixation portion 1710 at anotherside of the device 1700. The first connectors 1732 a can be shorter thanthe second connectors 1732 b such that the valve support 120 is closerto the fixation portion 1710 at the one side of the device compared toanother side of the device. The embodiment of the device 1700illustrated in FIG. 80E may advantageously position the valve support120 and prosthetic valve 130 further away from the LVOT to mitigateinterference with blood flow during ventricular contraction.Additionally, the embodiment of the device 1700 shown in FIG. 80E isexpected to provide a more uniform load distribution to accommodate forthe non-circular shape and saddle profile of the mitral valve annulus.

FIG. 80F illustrates an embodiment of the device 1700 in which theintegration region 1720 of the anchoring member 110 is attached to anintermediate portion of the valve support 120 as opposed to the end ofthe valve support 120. The embodiment of the device 1700 illustrated inFIG. 80F may reduce the interaction between the fixation portion 1710and valve function.

FIG. 80G illustrates another embodiment of the device 1700 in which thevalve support 120 has commissural attachment structures 128 that haveextensions 1728 that project radially inwardly from the downstream endof the commissural attachment structures. The extensions 1728 canconverge inwardly at a desired angle toward the central axis of thedevice 1700. In one embodiment, the angle of the extensions 1728maintains an appropriate minimum required bend radius so that theextensions 1728 can be linearized to minimize valve diameter duringplacement. The integration region 1720 of the anchoring member 110 canbe attached to the extensions 1728. The embodiment of the device 1700illustrated in FIG. 80G is expected to increase the minimum requiredbend radius for the connectors 1732, and reduce the height of thefixation portion 1710 for a given taper angle. The inward extensions1728 might also provide an advantageous attachment point for thecommissures of the valve tissue. By moving this attachment point furtherinto the ventricle and further towards the centerline of the valve, theoverall stresses on the valve tissue will be reduced. If the free edgesof the valve leaflets are slightly shorter than the commissures, theywill not touch these extensions 1728 in the open position. Thereforeblood flow will not be impeded, and the leaflets will not be damaged byrepeatedly touching the extensions.

FIG. 80H is a cross-sectional view of another embodiment of theprosthetic heart valve 1700 in accordance with the present technology.In this embodiment, the lateral portion 1730 has a continuouslyoutwardly flared shape from the downstream end 123 of the valve support120, and the integration region 1720 is at the terminus of the lateralportion 1730 where the anchoring member 110 is attached to the valvesupport 120. The first transition zone 1732 of the lateral portion 1730bends superiorly from the lateral portion 1730 to the orientation of thefixation portion 1710 such that the fixation portion 1710 is configuredto face the tissue of a native mitral valve. This embodiment thus showsa flared laterally extending lateral portion 1730.

FIG. 80I is a cross-sectional view of another embodiment of theprosthetic heart valve 1700 in accordance with the present technology.In this embodiment, the lateral portion 1730 has an outwardly projectingconical shape from the downstream end 123 of the valve support 120, andthe integration region 1720 is at the terminus of the lateral portion1730 where the anchoring member 110 is attached to the valve support120. The first transition zone 1732 of the lateral portion 1730 bendssuperiorly from the lateral portion 1730 to the orientation of thefixation portion 1710 such that the fixation portion 1710 is configuredto face the tissue of a native mitral valve. This embodiment thus showsa conical laterally extending lateral portion 1730.

FIG. 80J is a cross-sectional view of another embodiment of theprosthetic heart valve 1700 in accordance with the present technology.In this embodiment, the lateral portion 1730 has arms that are slightlyconvex when viewed from the downstream end, or concave when viewed fromthe upstream end. In this embodiment, the systolic blood pressureagainst the valve and valve support imparts a compressive column loadingon each of the arms. Due to the slightly bent shape of the arms, thisimparts a slight bending load on the arms in the downstream direction.At the same time, the systolic blood pressure against the armsthemselves and the attached sealing portions imparts a slight bendingload on the arms in the upstream direction. By optimizing the curvatureof the arms, the net bending load on the arms due to blood pressure canbe minimized or eliminated.

FIG. 80K is a cross-sectional view of another embodiment of theprosthetic heart valve 1700 in accordance with the present technology.In this embodiment, the lateral portion 1730 has a continuouslyoutwardly flared shape from a location at or near the upstream end 121of the valve support 120, and the integration region 1720 is at the peakof the lateral portion 1730 where the anchoring member 110 is attachedto the valve support 120. The first transition zone 1732 of the lateralportion 1730 bends from the lateral portion 1730 to the orientation ofthe fixation portion 1710 such that the fixation portion 1710 isconfigured to face the tissue of a native mitral valve. This embodimentthus shows an inverted flared laterally extending lateral portion 1730.Lateral portion 1730 may be integrally formed with fixation portion1710, or it may be a separate structure that is attached to fixationportion 1710 by welding or other suitable means. In the latter case, thetransition zone 1732 may bend either upwardly so that the tip of lateralportion 1730 points in an upstream direction, or downwardly so the tipof lateral portion 1730 points in a downstream direction.

FIGS. 80L and 80M are cross-sectional views of additional embodiments ofthe prosthetic heart valve 1700 in accordance with the presenttechnology. In these embodiments, the lateral portion 1730 extendsradially from a mid-section 118 of the valve support 120 (FIG. 80L) orfrom the upstream end 121 of the valve support 120 (FIG. 80M). In otherembodiments lateral portion 1730 may extend radially from a point at ornear the downstream end of valve support 120. Referring to FIGS. 80L and80M, the lateral portions 1730 can be have a serpentine or zig-zagcross-section and/or other configuration that is radially compressibleor deflectable to permit radial movement of the fixation portion 1710toward and away from the valve support 120, and that is resilient so asto bias the fixation portion 1710 radially away from the valve support120.

FIG. 80N is a cross-sectional view of another embodiment of theprosthetic heart valve 1700 in which the anchoring member 110 isinverted such that the fixation portion 1710 is located around thedownstream portion 123 of the valve support 120 and the integrationregion 1720 is attached to the upstream portion 121 of the valve support120. In this embodiment, the lateral portion 1730 has a continuouslyoutwardly flared shape from a point at or near the upstream end 121 ofthe valve support 120. This embodiment of the device 1700 positions thevalve support 120 further into the left atrium as opposed to the leftventricle.

FIG. 80O is a cross-sectional view of another embodiment of the heartvalve 1700 in which the fixation portion 1710 of the anchoring member110 is located around the mid-section 118 of the valve support 120. Inthis embodiment, the anchoring member 110 is attached to the valvesupport by a first lateral portion 1730 a having a continuouslyoutwardly flared shape from a point at or near the upstream end 121 ofthe valve support 120, and by a second lateral portion 1730 b having acontinuously outwardly flared shape from a point at or near thedownstream end 123 of the valve support 120.

FIG. 80P is a cross-sectional view of another embodiment of the heartvalve 1700 in which the fixation portion 1710 of the anchoring member110 is proportioned to be substantially coextensive with the valvesupport 120 in the axial or longitudinal direction. In this embodiment,the anchoring member 110 is attached to the valve support 120 by a firstlateral portion 1730 a extending from the integration region 1720located at the mid-section 118 of the valve support 118 and by a secondlateral portion 1730 b extending from the integration region 1720 at themid-section 118. The first and second lateral portions 1730 a, 1730 bmay be integrally formed with each other and/or with the fixationportion 1710.

FIG. 80Q is an isometric view of another embodiment of the prostheticheart valve device 1700 in accordance with the present technology. Inthis embodiment, the fixation portion 1710 includes an extension 1713that extends downstream from the first transition zone 1734. Theextension 1713 can be formed by extensions of selected structuralelements 1711 that project downstream beyond the area where thetransition zone 1734 comes into the fixation portion 1710. The extension1713 increases the height of the fixation portion 1710, and it furtherenhances sealing and ingrowth at the downstream portion of the fixationportion 1710. For example, the extension 1713 can enhance the ingrowthat the ventricular portion of the fixation portion 1710 of a mitralvalve device.

FIG. 81A is a cross-sectional view schematically showing a prostheticheart valve device 1900 in accordance with another embodiment of thepresent technology. The device 1900 can include an anchoring member 110,valve support 120, and prosthetic valve 130. The device 1900 can furtherinclude a compartment 1910 attached to one or both of the anchoringmember 110 and the valve support 120. The compartment 1910 can beconfigured to fit between the anchoring member 110 and the valve support120. The compartment 1920 can extend around only a portion of thecircumference of the anchoring member 110, or the compartment 1910 canextend around the entire inner circumference of the anchoring member110. The compartment 1910 can further include a second portion 1910 athat projects towards the left atrium to provide more space for packinginto a low-profile configuration.

In one embodiment, the compartment 1910 is made from a fabric, mesh,braid, porous material, or other suitable material that can contain amaterial 1920. The fabric, mesh, or other material might be optimized onone end to minimize blood flow through it during the initial periodafter implantation, while the other end might be more open to allow moreaggressive tissue ingrowth and even vascularization of the compartment1910. The material 1920, for example, can be a time-released agent thatinhibits or prevents clotting (e.g., clopidogrel or aspirin), a healingagent (ascorbic acid), or other agents that promote tissue and growth.The material 1920 can alternatively include structural filler elements,such as small spheres, random intermeshed fibers, foam, swellablehydrogels, etc., either in lieu of or in addition to anti-clotting andhealing agents. These small spheres, fiber, foam etc. might be optimizedfor their compressibility. In this way the structural filler elementscan provide structural support between the anchoring member 110 and thevalve support 120 without transmitting fully forces from the anchoringmember 110 to the valve support 120. The compartment 1910 can beattached to the anchoring member 110 or the valve support 120 byfasteners 1930, such as clasps, threaded ties, or other suitablefasteners. The material 1920 might be introduced into the device afterthe device has been deployed into the patient, for example via a tubewhich extends from the compartment 1910 to the proximal end of thedelivery system. Once the compartment 1910 has been filled with material1920, the tube can be pulled out of compartment 1910, with aself-sealing valve preventing leakage of material 1920 from thecompartment.

FIG. 81B is a top view of the prosthetic heart valve device 1900illustrating an embodiment in which the compartment 1910 has a pluralityof separate cells 1912 (identified individually as cells 1912 a-1912 g).Each of the cells 1912 can include the same material 1920 (FIG. 81A), ora number of the cells can include different materials 1920. For example,cells 1912 a, 1912 c, 1912 e, and 1912 g can include an anticlottingagent, and cells 1912 b, 1912 d, and 1912 f can include a healing agentto promote healing of connective tissues.

FIG. 82A is an isometric view of a prosthetic heart valve device 2000 inaccordance with another embodiment of the present technology, and FIG.82B is a cross-sectional view of the device 2000 along line 20B-20B inFIG. 20A. The device 2000 can include an anchoring member 110 having aframe and a plurality of tissue engaging elements 170 similar to thefixation portion 1710 of the devices 1700 described above. The device2000 can further include one or more fibers or webs 2010 that flexiblycouple the anchoring member 110 to the valve support 120. The webs 2010,for example, can be a fabric, mesh, braid, sheet, or other materialformed form a textile, polymer, metal, natural fiber, or other suitablematerials. These webs might have a variety of orientations.

Referring to FIG. 82B, the web 2010 can include a first portion 2012 atthe upstream end of the valve support 120, a second portion 2014 at thedownstream end of the valve support 120, and side portions 2016 attachedto the anchoring member 110 and the valve support 120 by fasteners 2020.The web 2010 illustrated in FIG. 82B can form an enclosed compartment2018 that can be filled with a material such as a time-release agentand/or filler elements as described above. The fasteners 2020 can besutures, other threaded ties, clasps, rivets or other suitable fasteningmeans. Additional fibers or webs might extend from the downstream end ofthe anchoring member to the upstream end of the valve support, from theupstream end of the anchoring member to the downstream end of the valvesupport, or in other directions. Alternatively, verticalradially-oriented planar webs may extend from the anchoring member tothe valve support.

The device 2000 illustrated in FIGS. 82A and 82B may provide very goodforce isolation between the anchoring member 110 and the valve support120 because there is no metal-to-metal interface and the suture-typefasteners 2020 add further stability and potentially better fatiguelife. The device 2000 has the potential for further improving fatiguelife because of the robust materials that can be used for the web 2010(e.g., Kevlar®, a trademark of E. I. du Pont de Nemours and Company) andthe flexibility of the web 2010.

FIG. 83 is a schematic cross-sectional view of the device 2000 inaccordance with another embodiment of the present technology. In thisembodiment, the web 2010 has a top portion between the upstream ends ofthe anchoring member 110 and the valve support 120, and the sideportions are connected to the anchoring member 110 and the valve support120 by fasteners 2020. The device 2000 in this embodiment furtherincludes tethers 2040 attached to the downstream end of the anchoringmember 110 and to an intermediate area of the valve support 120.

FIGS. 84A-84C are schematic cross-sectional views illustrating an aspectof several embodiments of the prosthetic heart valve devices 1700, 1900and 2000 in accordance with the present technology. Referring to FIG.84A, the device 1700 can have a fully expanded state in which thefixation portion 1710 extends from the lateral portion 1730 (e.g.,connecting structure) by an angel of 45° outwardly away from thelongitudinal axis of the device 1700 to an angle of −30° inwardly towardthe longitudinal axis of the device. The fixation portion 1710 extendsapproximately parallel to the longitudinal axis of the device in theembodiment shown in FIG. 84A. The device 1700 can have such a fullyexpanded state outside of the body or after the device 1700 has beenimplanted at a native valve. The fixation portion 1710, however, canflex or otherwise deform upon implantation such that the fixationportion 1710 at least partially adapts to the shape of the native valvelocation and deflects (arrow D) inwardly or outwardly to also at leastpartially adapt to the angular orientation of tissue at the native valvelocation. FIG. 84B, for example, shows deflection of the fixationportion 1710 inwardly to adapt to the angle of the tissue at theunderside of the native annulus (AN), and FIG. 84C shows deflection ofthe fixation portion 1710 outwardly to adapt to the angle of the tissueon the other side of the native annulus (AN). Such double conformabilityenhances the fixation of the device to the native tissue. Additionally,the fixation portion 1710 need not deflect with respect to the lateralportion 1730 at a mid-section of the fixation portion 1710 as shown insolid lines in FIG. 84A, but rather the fixation portion 1710 candeflect around areas that are at or near the ends of the fixationportion as shown by the transition areas of lateral sections 1730′ and1730″ shown in broken lines in FIG. 84A.

FIGS. 85A-85C are side views illustrating selected embodiments of thedeflection of the fixation portion 1710 relative to the lateral portion1730. Referring to FIG. 85A, the fixation portion 1710 can be connectedto the outer end of the lateral portion 1730 by a hinge 1737. In theembodiment shown in FIG. 85B, the fixation portion 1710 deflects aboutthe first transition zone 1734 where the lateral portion 1730 bends tothe fixation portion 1710. FIG. 85C shows an embodiment in which thefixation portion 1710 is attached to the lateral portion 1730 bymechanical fasteners 1738, such as pins, bolts, rivets, or otherfasteners. In any of these embodiments, the fixation member can pivot,rotate, flex or otherwise deflect to an inward orientation 1710′ or toan outward orientation 1710″ depending on the tissue at the implantsite.

FIGS. 86A-107B illustrate prosthetic heart valve devices 2100 havingextension members 2110 in accordance with additional embodiments of thepresent technology. Similar to the devices discussed above with respectto FIGS. 10A-85C, the devices 2100 include features such as the valvesupport 120 (e.g., FIG. 86B) having an interior 134 in which aprosthetic valve 130 (e.g., FIG. 86B) is coupled and an expandableanchoring member 110 (e.g., fixation member having a tubular fixationframe) coupled to the valve support 120 in a manner that mechanicallyisolates the valve support 120 from forces exerted upon the anchoringmember 110 when implanted. FIG. 86A is a side view and FIG. 86B is anisometric view of the device 2100 that includes features generallysimilar to the features of the prosthetic heart valve device 1700described above with reference to FIGS. 72-85C. Similar to the device1700, the anchoring member 110 can be coupled to the valve support 120such that a fixation portion 1710 of the anchoring member 110 isconfigured to engage native tissue on or downstream of the annulus so asto prevent migration of the device 2100 in the upstream direction.

In the embodiment illustrated in FIGS. 86A and 86B, the device 2100 alsoincludes an extension member 2110 extending from the anchoring member110 (e.g., from the fixation portion 1710 of the anchoring member 110).The extension member 2110 can be a brim, flange, shoulder or expansionring projecting from or tethered to the fixation portion 1710 of theanchoring member 110. In one embodiment, the extension member 2110 isconfigured to be positioned and to engage tissue upstream of the nativeannulus while the anchoring member 110 is configured to engage tissue ator near the annulus or leaflets. In some arrangements, the extensionmember 2110 is a self-expanding retainer configured to engage tissue inthe upstream heart chamber (e.g., left atrium) to (a) align and positionthe device 2100 within the native valve region such that the device 2100is accurately seated within the native valve to ensure proper engagementand retention by the surrounding tissue; and/or (b) assist invisualization and detection of device position relative to the anatomyduring implantation by deflecting, deforming, or otherwise moving inresponse to engagement with native tissue in a manner that can bevisualized using fluoroscopy, echocardiography, or other visualizationmethods; and/or (c) inhibit the device 2100 from moving in a downstreamdirection during operative use as a prosthetic valve in the heart of apatient.

Referring to FIG. 86A, the extension member 2110 can have an outercircumference 2112 with a cross-sectional transverse dimension D₄ thatis greater than the cross-sectional transverse dimension D1 of the outercircumference 150 of the upstream portion 112 (e.g., fixation portion1710) of the anchoring member 110 when the device 2100 is in theexpanded configuration 2102. In other embodiments, the extension member2110 may have a cross-sectional transverse dimension D₄ at least aslarge or even larger that the major axis 55 of the native annulus (FIG.14A). In some embodiments, the outer circumference 2112 of the extensionmember 2110 has a cross-sectional transverse dimension D₄ that isgreater than the supra-annular surface such that the extension member2110 is deflected by the walls of the atrium in an upstream directionwhen the extension member 2110 is deployed above the annulus. In someembodiments, the cross-sectional transverse dimension D₄ of theextension member 2110 can be approximately 1.2 to 3 times thecross-sectional dimension D₁ of the fixation portion 1710 of theanchoring member 110 when in a fully expanded, undeformed condition. Ina specific example, the extension member 2110 in a fully expanded,unbiased, undeformed condition, may have a transverse dimension D₄ inthe range of about 40 mm to about 150 mm, or about 40 mm to about 80 mm,for adult human patients. In some embodiments, extension member 2110 maybe non-circular in a transverse/horizontal plane (e.g. oval or D-shaped)and in such embodiments may have a major diameter in a range of about 40to about 150 mm, preferably about 40 to about 80 mm, the major diameterbeing about 1.2 to 2 times its minor diameter. Also in accordance withaspects of the present technology, the extension member 2110 may beprovided in multiple transverse dimensions and/or shapes to fit variousnative valve sizes allowing a surgeon to select the appropriate size andshape for each patient.

In some embodiments the extension member 2110 can be configured to alignthe device 2100 relative to the native annulus by engaging the tissueupstream of the native annulus. As the device is delivered to the targetsite via a delivery catheter (not shown), and as described in moredetail below, the extension member 2110 expands within the atrialchamber before the anchoring 110 member and valve support 120 arereleased from the delivery catheter at or near the annulus. In theseembodiments, the extension member 2110 can be rested on or pulled downagainst the supra-annular surface before the remainder of the device2100 (e.g., anchoring member 110 and valve support 120) is released froma delivery device. The total height (H_(t) FIG. 86A) of the device 2100and/or the fixation height (H_(f) FIG. 86A) of the fixation portion 1710can be configured such that when the extension member 2110 is engagingthe supra-annular surface, the fixation portion 1710 is properly alignedlongitudinally with respect to the native valve such that the fixationportion 1710 engages the desired annular and/or leaflet tissue. In otherembodiments, the extension member 2110 is configured to deflect ordeform when it engages the atrial walls or supra-annular surface whilethe remainder of the device 2100 is advanced in a downstream direction.The degree of deflection or deformation is correlated with thelongitudinal position of the fixation portion 1710 relative to thenative annulus such that, by visualizing the extension member 2110 usingfluoroscopy, echocardiography, or other means, the position of thedevice 2100 may be accurately determined prior to full deployment.

The extension member 2110 can be, in some examples, an extension ofmaterial either directly or indirectly coupled to the upstream portion112 (e.g., upper rim or upstream perimeter 113) of the anchoring member110 and which projects in a non-coaxial (or transverse) directionrelative to the anchoring member 110 when the device 2100 is in anexpanded configuration 2102. In a deployed configuration 2104 (see,e.g., FIG. 89B) at a native mitral valve, the extension member 2110 canextend upstream through the annulus AN and into a supra-annular spacewithin the atrium and engage the supra-annular surface or other atrialtissue with an outwardly extending flange or brim 2120.

The extension member 2110 may include the brim 2120 comprising acovering or sheet of material, such as a flexible fabric, ring, disk, orweb (e.g., a weave, braid or grating of fabric, shape-memory polymericmaterial, and/or shape-memory metal). In one embodiment, and as shown inFIGS. 86A and 86B, the brim 2120 can include a sheet of flexiblematerial coupled to the anchoring member 110 near the upstream end orportion 112 and extends radially outward from the anchoring member 110.In one example, the device 2100 can include a first sealing memberportion 140 a (FIG. 86B) coupled to a wall of the anchoring member 110(e.g., inner wall) and a second sealing member portion 140 b coupled toa wall of the valve support 120 (e.g., inner wall, outer wall). Asdescribed above with respect to the device 1700 illustrated in FIG. 72,the first and second sealing member portions 140 a and 140 b can beintegral portions of a single sealing member or can be separate sealingmembers that are attached independently to the anchoring member 120 andthe valve support 120. Likewise, in one embodiment, the brim 2120 canhave an inner edge 2122 that is coupled to the first sealing memberportion 140 a. For example, the brim 2120 and the first sealing memberportion 140 a can be a continuous sheet of material. In another example,the brim 2120 and the first sealing member portion 140 a can be coupledusing an attachment means, such as stitching, sutures, rivets, adhesiveor other mechanical coupling fasteners or features known in the art. Insuch embodiments, the brim 2120 and the first sealing member portion 140a may be formed of the same material or different materials. In aparticular example, the first sealing member portion 140 a and the brim2120 can be formed of an impermeable material for preventingperivascular leaks between the device 2100 and the adjacent tissueand/or to promote in-growth of tissue of adjacent tissue (e.g., Dacron®or tissue such as pericardium). In another example, the brim 2120 can beformed of a different material having a desired flexion or shape-memoryfeature (e.g., shape-memory metal), or a combination of metal, fabric,tissue and/or other materials.

The extension member 2110 may further include tissue engaging elements170 a, such as barbs, bumps, tines, rods or similar structures,integrated therewith, or bonded or otherwise attached thereto, similarto those optionally included on the sealing member 140 as describedabove in connection with FIG. 43A-43B. These tissue engaging elements170 a may be configured to engage atrial wall or supra-annular tissue toinhibit movement of the device 2100 in a downstream direction (towardthe ventricle). The tissue engaging elements 170 a may benon-penetrating or may penetrate the tissue surface slightly to inhibitmovement. In exemplary embodiments, the tissue engaging elements can beoriented to point preferentially in a downstream direction to havehigher retention force against movement in the downstream direction thanin the upstream direction. Alternatively or additionally, the outer,tissue-facing surface of the extension member 2110 may be coated with apermanent or temporary adhesive or other material to enhance frictionand/or to adhere to the native tissue, at least until tissue in-growthhas occurred sufficiently to inhibit device movement.

In some embodiments, the extension member 2110 can also include asupport structure 2130 coupled to or, in other embodiments, integralwith the brim 2120 (FIG. 86B). The support structure 2130 can providethe extension member 2110 with additional rigidity as the extensionmember 2110 extends radially out from the anchoring member 110 when thedevice 2100 is in the expanded configuration 2102. In severalarrangements, the support structure 2130 can be a stiffening memberformed from metal and/or a polymeric material that is sewn, sutured, oradhered to the brim 2120. In some embodiments, the support structure2130 can include a resilient metal or polymer mesh, ring or series ofrings coupled to or otherwise integrated into a portion of the brim2120. In certain embodiments, the support structure 2130 can be formedfrom a deformable material or a resilient or shape memory material(e.g., Nitinol). In other embodiments, the support structure 2130 caninclude one or more stiffening members, such as wires 2132 or strutsthat are secured to the outer surface or positioned within the materialof the brim 2120 (FIG. 86B).

In one embodiment, the support structure 2130 can be separate from theframe 2109 and/or the anchoring member 110. For example, FIG. 86Billustrates an embodiment in which the support structure 2130 includeswires 2132 (e.g., a plurality of struts) formed in a crisscrossingserpentine configuration that form a continuous ring around theextension member 2110 and in which the wires 2132 are not in directcontact with the frame 2109. In this embodiment, the extension member2110 is connected to the anchoring member 110 (e.g., at the fixationportion 1710) by the material of the brim 2120 (e.g. fabric or tissue).In some embodiments, the extension member 2110 (including the brim 2120and any support structure 2130) is connected to the anchoring member 110only by fabric, suture, or other highly flexible, non-metal elements.Accordingly, in this embodiment, the wires 2132 are structurallyindependent from the anchoring member 110 such that the supportstructure 2130 is indirectly coupled to the frame 2109 by the brim 2120(e.g., fabric, material, etc.). As such, the support structure 2130, inan undeformed or unbiased condition, is spaced apart from the frame 2109of the anchoring member 110 and is mechanically isolated from the frame2109. While the embodiment illustrated in FIG. 86B illustrates agenerally concentric arrangement of the wires forming a crisscrossingserpentine pattern (e.g., zig-zag pattern, diamond pattern), otherarrangements and patterns (e.g., serpentine, wavy, radial arms, square,etc.) can also be formed to provide a desired rigidity to the extensionmember 2110, and as described below with respect to FIGS. 87A-107B.

In a further embodiment, and as illustrated in FIGS. 87A and 87B, thesupport structure 2130 can be integral with the frame 2109 (e.g.,Nitinol frame) of the anchoring member 110. FIGS. 87A and 87B are sideand top views, respectively, of a device 2100 having an extension member2110 that includes a support structure 2130 formed from an extension ofthe frame 2109. For example, the support structure 2130 includesintegral wires 2134 (e.g., struts) extending from the structuralelements 2111 of the frame 2109 into the brim 2120 (FIG. 87A, dottedlines). As illustrated in FIG. 87B, the integral wires 2134 can bearranged in a pattern (e.g., a combination of straight, outwardlyprojecting struts 2134 a and triangular-oriented struts 2134 b) forproviding a desired combination of rigidity and flexibility about thebrim 2120. In some embodiments, the integral wires 2134 connecting thesupport structure 2130 to the frame 2109, due to their number,dimensions, geometrical arrangement, or other aspect, are individuallyor collectively substantially more flexible than the structural elementsof the frame 2109 so that the extension member 2109 is comparativelyeasily deflected or deformed when it engages native tissue. For example,the number of integral wires 2134 interconnecting extension member 2110to frame 2109 around the circumference of the device 2100 may besubstantially fewer than the number of structural elements 2111 aroundthe circumference.

In another embodiment, the support structure 2130 can be connected tothe frame 2109 at one or more connection points using rivets, (e.g.Nitinol rivets), threads, adhesives, solder, laser welding, metal boltsor other mechanical features, or other types of fasteners can be used tosecure the support structure 2130 to the frame 2109 of the anchoringmember 110. In some arrangements, the support structure 2130 can becoupled to the frame 2109 with a plurality of flexible connectingmembers (not shown) that are substantially less rigid than the frame2109. In this embodiment, the flexibility of the extension member 2110can allow the extension member 2110 to distort without distorting theanchoring member 110 and/or the valve support 110. Various aspects ofthis arrangement can allow the extension member 2110 to be conformableand, in some embodiments, more atraumatic to the supra-annular tissueand atrial wall. In some embodiments, the wires 2132 or struts can havea rigidity or stiffness that is less than the rigidity of stiffness ofthe structural elements 2111 of the frame 2109. In these embodiments,the extension member 2110 may be deformed by the surroundingsupra-annular tissue and/or atrial walls without transmitting forces tothe more rigid frame structure of the anchoring member 110.

FIGS. 88A-88C are cross-sectional views of a heart showing a method ofdelivering a prosthetic heart valve device 2100 to a native mitral valveMV in the heart using a trans-apical approach in accordance with anotherembodiment of the present technology. Referring to FIG. 88A, thedelivery catheter 18 is advanced through guiding catheter (not shown)which enters the left ventricle LV of the heart through a puncture inthe left ventricle wall at or near the apex of the heart and is sealedby a purse-string suture. Alternatively, the delivery catheter 18 may beplaced directly through a purse-string-sealed trans-apical incisionwithout a guiding catheter. The sheath 20, which contains a collapseddevice 2100 in a radially contracted delivery configuration 2106, isadvanced through the mitral annulus AN between native leaflets LF asshown in FIG. 88A. The valve support 120, the anchoring member 110 andthe extension member 2110 (e.g., brim, flange, shoulder, expansion ring,etc.) have a low profile configured for delivery through the deliverycatheter 18 positioned at or near the native mitral valve when in thedelivery configuration 2106. Referring to FIGS. 88B-88C together, oncethe device is positioned so that the extension member 2110 is located inthe atrium, the sheath 20 is pulled proximally to allow the device 2100to expand to the radially expanded and/or deployed configurations 2102,2104 (FIGS. 88B and 88C).

As with other devices disclosed herein, retraction of the sheath 20allows the device 2100 to expand while the delivery system remainsconnected to the device 2100 (e.g., system eyelets, not shown, areconnected to the device eyelets, not shown). In this manner, an operatorcan control the placement of the device 2100 while at least portions ofthe device 2100 (e.g., the extension member 2110, upstream portion 112of the anchoring member 110) are in the expanded configuration 2102(FIGS. 88B and 88C). For example, as the sheath 20 is disengaged fromthe device 2100, the extension member 2110 can expand within the leftatrium while the upstream region 112 of the anchoring member 110 isretained within the sheath 20 (FIG. 88B). During this phase of thedelivery, the position of the device 2100 within the mitral valve areacan be adjusted or altered.

In one embodiment, the extension member 2110 can have an indicatorportion 2116 (FIGS. 88C and 89B) that can be visualized during deviceimplantation to determine the position of the device 2100 relative tothe native annulus. In one embodiment, deflection of the indicatorportion 2116 caused by engagement of the extension member 2110 with awall of the left atrium (e.g., when treating the mitral valve) can bevisualized to accurately determine the position of the device 2100relative to the native annulus. In some arrangements, the indicatorportion 2116 preferably deflects about an axis generally parallel to aplane containing the native annulus. In another arrangement, theindicator portion 2116 forms an angle with a plane containing the nativeannulus, wherein the angle increases as the indicator portion 2116 isdeflected. In a particular positioning and deployment step, theextension member 2110 can be placed such that the indicator portion 2116forms a first angle with the plane during the visualization step andthen the device 2100 is moved such that the indicator portion 2116 formsa second angle with the plane less than the first angle before theanchoring member 110 is deployed. Because the position of the fixationportion 1710 (FIG. 86A) relative to the extension member 2110 is knownfor a given degree of deflection, the position of the fixation portion1710 relative to the native annulus can be determined based upon degreeof deflection (i.e. second angle) of the extension member 2110. Theindicator portion 2116, for example, can include a radiopaque materialcoupled to or integrated with the brim 2120 and/or the support structure2130, and the radiopaque material can visualized using fluoroscopy.

In another example, the indicator portion 2116 can include an echogenicmaterial that is visualized using ultrasound. The indicator portion mayinclude, in a further embodiment, one or more metallic members. In someembodiments, the device 2100 can also include gas (e.g. CO₂) pockets orchambers (not shown) within or associated with the extension member 2110that enhance echocardiographic visibility. For example, the extensionmember 2110 can be made of closed cell foam or other material withtrapped gas pockets. In another embodiment, the extension member 2110(e.g., the support structure 2130) can include a platinum core wire forenhancing fluoroscopic visibility. The platinum core wire can beremovable such that once the device 2100 is properly positioned andimplanted, the platinum core wire can be removed to avoid a galvanicresponse with NiTi wires.

After the device 2100 is located at the target site, the sheath 20 canbe fully removed from the device 2100 and the anchoring member 110 ofthe device 2100 can expand outwardly to engage subannular tissue, suchas the leaflets LF, and to retain the device 2100 in the desired targetlocation. Following positioning and deployment of the device 2100 wherethe extension member 2110 is positioned and conformed to tissue abovethe annulus and the anchoring member 110 is engaging the annular and/orsubannular tissue, the pull-wires (not shown) may be retracted in aproximal direction to release the device 2100 from the delivery system.The delivery system can then be removed to thereby fully implant thedevice 2100 at the mitral valve MV in the deployed configuration 2104.Alternatively, the device 2100 may be expanded upstream or downstream ofthe desired target location then pulled or pushed downstream orupstream, respectively, into the target location before releasing thedevice 2100 from delivery system.

FIGS. 89A and 89B are schematic top views of a native mitral valve inthe heart viewed from the left atrium and showing the prosthetictreatment device of FIGS. 86A and 86B implanted at the native mitralvalve in accordance with an embodiment of the present technology. Duringdeployment, the device 2100 is configured to transition from a radiallycontracted delivery configuration (FIG. 88A) to an unbiased/expandedconfiguration 2102 (FIG. 89A) in which the extension member 2110 expandsradially outward from the anchoring member 110 (e.g., the upstreamperimeter 113 and/or the fixation portion 1710) over the supra-annularsurface of the native valve and/or the atrial wall surrounding thenative valve. Prior to completely releasing the device 2100 from thedelivery catheter, the catheter may be moved in a downstream direction(toward the ventricle) to position the fixation portion at the desiredlocation relative to the native annulus (FIGS. 88B-88C). In doing so,the outer portion of the extension member 2110 may be deflected upwardand radially inward due to contact with the atrial tissue (FIGS. 88C and89B). This deflection can be visualized using fluoroscopy and/orechocardiography, thereby indicating to the practitioner thelongitudinal position of the device 2100. As illustrated in FIG. 89B,the device 2100 can assume a final deployed configuration 2104 in whichat least a portion of the extension member 2110 engages and is at leastpartially deformed by a supra-annular surface or tissue above the nativevalve (e.g., an atrial wall).

In many embodiments, the extension member 2110 can have sufficientflexibility such that the extension member 2110 conforms tosupra-annular and atrial wall anatomy when in the deployed configuration2104 (FIG. 89B). Accordingly, during implantation at a native valve(e.g., native mitral valve), the extension member 2110 can be deformedor deflected by the native tissue from its bias toward the expandedconfiguration 2102 to the deployed configuration 2104 in which itextends further in an upstream direction (FIG. 89B). Although theextension member 2110 is deflectable in an upstream direction (FIG.89B), the extension member 2110 is resiliently biased to return to theunbiased configuration (FIGS. 86A-87B and 89A) where it to radiallyextends and pushes downward against the supra-annular surface. This biascontributes to the retention of the extension member 2110 in the atrium(e.g., resist movement toward the left ventricle under axial compressiveforces during diastole and/or atrial contraction) and the maintenance ofthe positioning of the device 2100 with respect to the native valveannulus. Furthermore, the resulting compression fit between theextension member 2110 and the supra-annular surface and/or atrial wallsor other structures helps create a long-term bond between the tissue andthe device 2100 by encouraging tissue ingrowth (e.g., into the brim2120) and encapsulation.

The flexible characteristics of the structural elements 2111 of theframe 2109 (FIG. 86A) having the first sealing member portion 140 a andthe support structure 2130 and brim 2120 can allow for the flexibilityand conformability of the anchoring member 110 and extension member2110, respectively, to engage and seal the device 2100 against unevenand uniquely-shaped native tissue at the native mitral valve. Althoughthe extension member 2110 and the anchoring member 110 are deformable inresponse to forces exerted by the native anatomy, the valve support 120can be substantially isolated from such deformation and/or can havesufficient rigidity to maintain a circular or other originalcross-sectional shape, thus ensuring proper coaptation of the leafletsof the prosthetic valve 130 when implanted. The mechanical isolation ofthe prosthetic valve 130 from the forces exerted by the native tissuemay be achieved by the independent deformability of the portion of theanchoring member 110 that is spaced apart from the valve support 102 aswell as the independent deformability and atrial positioning of theextension member 2110.

As described above, mechanical isolation of the valve support 120 fromthe anchoring member 110 may be attributed to several aspects of theprosthetic heart valve devices disclosed herein. Some of these aspectscan include, but not be limited to, (a) the relative high flexibility ofthe anchoring member 110, or flexibility of the transverse elementsconnecting the fixation portion 1710 of the anchoring member 110 to thevalve support 120, compared with the lower flexibility of the valvesupport 120; (b) radial spacing between the anchoring member 110 and thevalve support 120, particularly in some embodiments, at the upstreamportion/upstream end where the anchoring member 110 engages the nativeannulus and/or subannular tissue; and (c) the coupling mechanismsemployed to attach the anchoring member 110 to the valve support 120(e.g. connection structure 1720/1730, FIG. 73) can be configured (e.g.,to be flexible, compressible, or moveable) so as to reduce thetransmission of forces from the anchoring member 110 to the valvesupport 120.

In the device 2100, the anchoring member 110 can also be mechanicallyisolated from the extension member 2110. When deployed at a nativemitral valve, the extension member 2110 is more substantially influencedby anatomical tissue forces of the atrium and by atrial diastolicforces, whereas the anchoring member 110 is more substantiallyinfluenced by anatomical tissue forces at or near (e.g., below) theannulus and/or by ventricular systolic forces. The device 2100 isconfigured to conform to the shape and motion of the anatomy under theseseparate forces by mechanically isolating the anchoring member 110 fromthe extension member 2110 as well as from the valve support 120. In oneembodiment, the extension member 2110 can have a relative highflexibility compared to the flexibility of the anchoring member 110and/or the valve support 120 such that the extension member 2110 candeform significantly when deployed and in when in operation withoutsubstantially affecting the deformation of the anchoring member 110. Inanother embodiment, the extension member 2110 can have a deformableportion 2114 (FIG. 89A) that is mechanically isolated from the anchoringmember 110 such that the deformable portion 2114 is radially and/orlongitudinally deformable without substantially deforming the anchoringmember 110. The extension member 2110 can also be coupled to theanchoring member 110 in a manner and at a location (e.g., upper rim orupstream perimeter 113) that allows for deformability of the extensionmember 2110 without substantially affecting the shape of the anchoringmember 110 or the valve support 120. Moreover, the coupling mechanismsemployed to attach the extension member 2110 to the anchoring member 110can be configured (e.g., to be flexible or moveable) so as to reduce thetransmission of forces from the extension member 2110 to the anchoringmember 110 or vice versa.

FIGS. 90A-90F are schematic illustrations showing how the prostheticheart valve device mechanically isolates the valve support 120 from theforces exerted by the native tissue in accordance with additionalembodiments of the present technology. Reference to forces exerted bythe native tissue can include, in some examples, the diastolic andsystolic forces generated in the beating heart, or in other examples,can include forces exerted by anatomical differences in the native valvethat can vary patient to patient. In one embodiment, shown in FIG. 90A,lateral forces F_(H1) exerted on the device 2100 are absorbed by theanchoring member 110 and/or the extension member 2110, such that thevalve support 120 is not deformed by the forces F_(H1). In thisembodiment, the device 2100 can have a central longitudinal axis L-L andthe lateral forces F_(H1) can deform or otherwise move the anchoringmember 110 and extension member 2110 into different laterally offsetpositions relative to the axis L-L, while the valve support 120 does notsubstantially move with respect to the axis L-L. The extension member2110 is also mechanically isolated from the anchoring member 110 suchthat the anchoring member 110 can be moved a first distance DIS₁ in adirection transverse to longitudinal axis L-L and the extension member2110 can move a second distance DIS₂ in the transverse direction that isgreater than, equal to or, in another embodiment, less than the distanceDIS₁. In some cases, all three elements (anchoring member 110, extensionmember 2110, and valve support 120) can be in three different offsetpositions in the transverse direction relative to axis L-L.

In another embodiment, multiple moment forces F_(A1) and F_(A2) exertedon the device 2100 from the native tissue can also be absorbed by theanchoring member 110 and/or the extension member 2110 (FIG. 90B). Forexample, the moment forces F_(A1), F_(A2) exerted by the native tissuecan independently alter the positioning (e.g., X-Y positioning,rotational positioning, etc.) with respect to the central longitudinalaxis of the anchoring member 110, extension member 2110 and valvesupport 120 such that each element is at a different angle relative tothe longitudinal axis L-L. As illustrated in FIG. 90B, the extensionmember 2110 can deform, tilt, or move angularly independently of thedeformation or angle of the anchoring member 110, and vice versa.

In a further embodiment, the anchoring member 110 and extension member2110 can undergo relative shape changes with respect to the expandedconfiguration 2102 (e.g., FIGS. 86A and 86B) when forces transmittedfrom the surrounding tissue are absorbed by the anchoring member 110 andthe extension member 2110. In the examples illustrated in FIGS. 90C-90E,transverse compressive forces, can be absorbed by portions of theanchoring member 110 and/or the extension member 2110, such that thedevice 2100 is positioned and retained at the native valve site and sothat the valve support 120 remains substantially un-deformed under thesame conditions. In one embodiment, absorption of transverse compressiveforces F_(H2) and F_(H3) by the anchoring member 110 can cause theupstream portion 112 of the anchoring member 110 to deform inwardlywithout or less deformation of the extension member 2110 under the sameand/or different applied forces (FIG. 90C). Alternatively, thedownstream end of the extension member 2110 may be deformed in thetransverse direction without or with less deformation of the upstreamend of the anchoring member 110.

In other embodiments, as illustrated in FIGS. 90D and 90E, forces canchange the shape of the extension member 2110 in the horizontal planeinto a shape that is different than the shape of the anchoring member110 resulting from the same or different forces. For example, theextension member 2110 can be subjected to different horizontal forcesF_(H4) and F_(H5) (e.g., within the atrium) than the forces F_(H2) andF_(H3) (e.g., at the annulus or downstream of the annulus) exerted onthe anchoring member 110 (FIG. 90D). As a result, extension member 2110may be ovalized with its major axis in a first direction, whileanchoring member 110 is ovalized with its major axis in a seconddirection transverse to the first direction. FIG. 90E illustratesanother embodiment in which lateral forces F_(H2), F_(H3), F_(H4) andF_(H5) are absorbed by the extension member 2110 and the anchoringmember 110 such that the extension member 2110 is deformed into aD-shape, while the anchoring member 110 has a different shape—e.g.circular, oval, or a non-aligned D-shape—in the horizontal plane.

FIG. 90F illustrates an embodiment in which the anchoring member 110 andextension member 2110 undergo relative shape changes in the expandedconfiguration 2102 when longitudinal forces F_(L1) and F_(L2)transmitted from the surrounding tissue are absorbed by the anchoringmember 110 and the extension member 2110. In this embodiment,longitudinal mechanical forces F_(L1) and F_(L2) can cause distortion ofthe extension member 2110 and the anchoring member 110, such that theseelements have side profiles with different shapes along a transverseaxis T-T of the device 2100. For example, extension member 2110 may havea saddle shape corresponding to the shape of the supra-annular surfaceof the native valve, while anchoring member 110 remains substantiallycylindrical or is deformed into a different shape, e.g. with an archedside profile.

FIG. 91A is an isometric illustration of another device 2100 having anextension member 2110 in accordance with the present technology. Theextension member 2110 shown in FIG. 91A includes the brim 2120 formed offabric or another suitable material, wherein the brim material 2124 hasstructure features such as folds 2125 in the fabric that are at least inpart configured to provide the support structure 2130 of the extensionmember 2110. The folds 2125 can be sewn, sutured, secured with adhesive,or formed using other mechanical features such as staples. The folds2125 in the brim material 2124 can be patterned or positioned fordesired strength, rigidity and/or flexibility. For example, folds 2125can have concentric, radial, zig-zag, serpentine, diamond, square orother patterns in the brim 2120. Optionally, one or more structuralelements (e.g., metal wires, plastic elements, etc.) can be sewn orattached to the brim 2120 and/or placed within the fold(s) 2125 toprovided added structure.

FIG. 91B is a cross-sectional view of the folds 2125 in the extensionmember 2110 shown in FIG. 91A. The folds 2125 can be sewn or securedportions of the brim material 2124 arranged in a spaced-apart mannercircumferentially, radially or in another pattern about the brim 2120.Some folds 2125 a do not have additional elements incorporated, whileother folds 2125 b may have structural elements such as wires 2132positioned within the fold 2125 b (FIG. 91B). In some embodiments, thestructural elements or other elements can be radiopaque to assistvisualization of the device during and post implantation at the nativevalve. The device 2100 illustrated in FIGS. 91A and 91B, provides acompliant, easily compressible, and atraumatic extension member 2110that does not apply or transmit deforming forces to the anchoring member110 or the valve support 120.

FIGS. 92-95B are schematic top views of several additional embodimentsof prosthetic heart valve devices 2100 in accordance with the presenttechnology. Like reference numbers refer to similar or identicalcomponents in FIGS. 86A-95B. The embodiment of the device 2100illustrated in FIG. 92 represents several of the embodiments describedabove with reference to FIGS. 86A-91B. In this embodiment, the extensionmember 2110 includes a support structure 2130 including a wire 2132forming a series of loops 2135 positioned circumferentially around thebrim 2120. The loops 2135 may provide increased resilience in the brim2120 while still providing sufficient flexibility for the extensionmember 2110 to be deflected in an upstream direction. Moreover, theloops 2135 may provide a support structure 2130 that atraumaticallyengages tissue.

FIG. 93 illustrates an embodiment of the device 2100 in which thesupport structure 2130 includes a plurality of wavy, concentric wires2132 positioned circumferentially around the brim 2120. FIG. 94illustrates an embodiment of the device 2100 in which the supportstructure 2130 includes a spiral/helical formed wire 2132, 2136positioned circumferentially around the brim 2120. While the illustratedembodiment of FIG. 94 includes a single wire 2132 formed in a concentricspiral/helical pattern, other wires (not shown) could be included toform the spiral/helical pattern or another pattern (e.g., a doublehelix, double spiral, etc.). The support structures 2130 illustrated inFIGS. 93 and 94 can provide axial strength while maintaining sufficientflexibility to conform and deflect relative to the anchoring member 110about an axis transverse to the direction of blood flow through theprosthetic valve 130.

FIGS. 95A and 95B illustrate additional embodiments of the device 2100in which the support structure 2130 includes a plurality of spirallyprojecting spokes 2136 connected to or otherwise integral with the frame2109 of the anchoring member 110 and extending radially toward the outercircumference 2112 of the extension member 2110. The spokes 2136 canhave an atraumatic tip 2137 and/or tissue engaging portion such that thesupra-annular tissue and/or atrial wall is undamaged during deploymentor engagement by the extension member 2110. In some embodiments theatraumatic tip 2137 can be a looped portion 2137 a at the end of thespoke 2136 (FIG. 95A). In other embodiments, the atraumatic tip 2137 canbe a bent portion 2137 b.

FIGS. 96A-96C illustrate another embodiment of the device 2100 having asupport structure 2130 with atraumatic features. As shown in FIGS. 96Aand 96B, the device 2100 includes a rounded or curvilinear extensionmember 2110 having a plurality of resilient coils 2138 coupled to thebrim 2120. In one embodiment, the extension member 2110 shown in FIG.96A is configured to conform to the native anatomy without inducingtrauma. The extension member 2110 can also enhance self-alignment of thedevice 2100 (e.g., mitigate tilting relative to the annulus). Forexample, the extension member 2110 can counteract against forces thatwould cause the device 2100 to tilt during systole. Further, one or morecomponents of the extension member 2110 can be used to visualize theshape of the extension member 2110 and thereby detect or locate thedevice 2100 during deployment.

The coils 2138 can extend from the frame 2109 of the anchoring member110 toward the outer circumference 2112 of the extension member 2110(FIG. 96B), or in another embodiment, the coils 2138 can be spaced apartfrom the frame 2109. In one embodiment, the coils 2138 are deflectablein at least an upward direction, but are biased toward a radiallyoutward orientation with a rounded, downward oriented end 2139. In oneembodiment, the coils 2138 can wound from Nitinol (NiTi), polyetherether ketone (PEEK) polymer, stainless steel or other suitablematerials. In various embodiments, the coils 2138 include shape-memorymetal. In a further embodiment, the extension member 2110 can includethe brim 2120 formed from a fabric, woven material, knitted material,mesh or web made from polyester or other flexible materials (FIG. 96C).In yet a further embodiment, the brim 2120 can be formed from a web,mesh, knitted material or other woven material made from NiTi, stainlesssteel, (PEEK) polymer, or other suitable materials that can be used toform the brim 2120 alone or in combination with another material (e.g.,integrated into the weave of) that is used to form the brim 2120. Asshown in FIGS. 96A-96C, the extension member 2110 can be shaped toprovide sealing between the native tissue and the device 2100 when thevalve is closed and under pressure during ventricular systole. Theextension member of FIGS. 96A-96C can also promote bio-integration oftissue into the material of the brim 2120, which can then promotelong-term sealing of the device 2100 to the native tissue.

FIGS. 97A and 97B illustrate a further embodiment of the device 2100 inwhich the extension member 2110 includes a discontinuous brim 2120around the upstream perimeter 113 of the anchoring member 110 inaccordance with the present technology. FIGS. 97A and 97B are top andisometric views of a device 2100 having an extension member 2110 thatincludes a plurality of discreet extending petals 2140 or protrusionsextending from the frame 2109 of the anchoring member 110. The petals2140 can include wires 2132 or struts radially extending from the frame2109 to form a plurality of spaced apart triangular-shaped petals 2140around the upstream perimeter 113 of the anchoring member 110. The wires2132 can be covered with fabric or other brim material 2124 in acontinuous or discontinuous (FIGS. 97A and 97B) manner to define thebrim 2120. The petals 2140 are mechanically isolated from each otherpetal 2140 and each petal 2140 is configured to be deflected and/ordeformed independently of each other petal 2140 to provide enhancedconformity to the native tissue.

FIGS. 98A-98C illustrate additional embodiments of the device 2100 inwhich the extension member 2110 includes a plurality of petals 2140radially extending from the frame 2109 of the anchoring member 110. Forexample, FIG. 98A illustrates a device 2100 having a plurality ofcircular-shaped wires 2141 forming individual petals 2140. Thecircular-shaped wires 2141 can be flexibly connected via a plurality ofconnectors 2142 to the frame 2109 around the upstream perimeter 113 ofthe anchoring member 110. Additionally, the circular-shaped wires 2141can be covered or otherwise attached to brim material 2124 for formingthe brim 2120 (see FIGS. 98B and 98C). In one embodiment, the extensionmember 2110 includes a fabric or other material over and/or under thecircular-shaped wires 2141 and extending beyond the circular-shapedwires 2141 to form a continuous brim 2120 (FIG. 98B). FIG. 98Cillustrates another embodiment in which the circular-shaped wires areadhered to discreet portions of brim material 2124 to form spaced apartcircular-shaped petals 2140 around the upstream perimeter 113 of theanchoring member 110. In this example, each petal 2140 can bemechanically isolated from each adjacent petal 2140 and such that thepetals 2140 can be deflected and/or deformed independently of each otherpetal 2140 to provide the extension member 2110 enhanced conformity tothe surrounding native tissue. In further embodiments, the petals 2140can be connected or hinged to adjacent petals 2140 (FIG. 98B) with links2143 or other fasteners to provide some cohesive movement within thebrim 2120 while still allowing more freedom for conformity of uniquetissue anatomy engaged by the extension member 2110.

FIG. 99 illustrates an additional embodiment of the device 2100 havingan extension member 2110 formed of a polymeric sheet 2118 or otherpanel. In various arrangements, the polymeric sheet 2118 can providesufficient strength or/or rigidity such that the extension member 2110does not need support wires and/or can allow for fewer wires or smallerwires to be used to form a support structure (not shown). To provideflexibility to the extension member 2110, certain embodiments of thepolymeric sheet 2118 include a plurality of holes 2119 through thepolymeric sheet material. The holes 2119 can be selected for density,size and/or position on the polymeric sheet 2118 can be varied toincrease and/or decrease flexibility of selected regions the extensionmember 2110. For example, FIG. 99 illustrates an embodiment of thedevice 2100 in which holes 2119 are placed in the polymeric sheet 2118at greater density toward the outer circumference 2112 when compared tothe density at an inner portion 2113 of the polymeric sheet 2118. Inthis example, the flexibility of the extension member 2110 is greatertowards the outer circumference 2112 than at the inner portion 2113allowing the region at or near the outer circumference 2112 to morereadily deform and conform to the native tissue. In some embodiments,not shown, the density and/or size of the holes 2119 can be unevenlydistributed across the polymeric sheet 2118 to form a non-uniformextension member 2110. For example, it may be desirable to providegreater flexibility (e.g., greater density of holes 2118) on the sideengaging the anterior leaflet than on the side engaging the posteriorleaflet such that the device 2100 will not substantially occlude theLVOT.

FIGS. 100A and 100B illustrate another embodiment of the device 2100having an extension member 2110 with variable flexibility during andfollowing implantation in accordance with the present technology. FIG.100A illustrates the expanded device 2100, 2102 after release from adelivery catheter 18, and FIG. 100B is a schematic top view of thedevice 2100. Referring to FIGS. 100A and 100B together, the supportstructure 2130 can include a combination of wires having variablestiffness (e.g., flexibility). For example, the support structure 2130can include flexible wires 2144 (e.g., thin, floppy) and includerelatively stiffer wires 2145 that are less flexible than the flexiblewires 2144. The stiffer wires 2145 may also have higher radiopacity thanthe flexible wires 2144 so as to facilitate enhanced visualizationduring device placement. In some embodiments, the stiffer wires 2145 canbe positioned within pockets or sleeves 2146 within or attached to thebrim 2120 such that the stiffer wires 2145 can be removable during orafter implantation of the device 2100. The sleeves 2146 may be orientedsuch the stiffer wires 2145 provide radial support to the extensionmember 2110 during deployment and implantation (FIG. 100B); howeverother orientations and arrangements are also possible. As shown in FIG.100A, the stiffer wires 2145 can remain connected to the deliverycatheter 18. After placement of the extension member 2110 upstream ofthe native valve, the stiffer wires 2145 can be removed from the sleeves2146 and retracted through the deliver catheter 18. In some embodiments,all the stiffer wires 2145 can be removed, however, in otherarrangements, a portion of the stiffer wires 2145 or select stifferwires can remain within the extension member 2110 followingimplantation. The flexible wires 2144 can remain coupled to the brim2120 to provide an atraumatic support structure 2130 having increasedflexibility once implanted.

FIG. 101 illustrates an embodiment of the device 2100 in which thesupport structure 2130 includes one or more inflatable chambers 2147within the brim 2120 that can be inflated with fluid to provide radialstiffness to the extension member 2110. The brim material 2124 can be afabric, polymer or other material, for example, that provides theinflatable chambers 2147 (e.g., internal channels). One or moreindependent or interconnected inflatable chambers 2147 can be arrangedin a continuous ring around the extension member 2110, or in otherarrangements (e.g., radially extending arms, zig-zags, etc.) In oneembodiment, the chambers 2147 are fillable with fluid (e.g., saline,CO₂, air, gel, contrast agent, etc.) via a port 2148 provided on thebrim 2120 either before, during, or after deployment of the device 2100.In one embodiment, the chambers 2147 can be at least partially filledduring deployment and the volume of the internal fluid can be adjustedafter deployment of the extension member 2110 and/or the device 2100 toprovide a desired degree of flexibility. In various embodiments, thechambers 2147 can be inflated temporarily, permanently, or be deflatedbefore the release of the device 2100 from the delivery catheter (notshown). In one embodiment, the extension member 2110 has radialstiffness only when inflated. The extension member 2110 can bestructurally independent from the anchoring member 110, for example,attached via the brim material 2124 or via flexible connectors (notshown). In some embodiments, the inflation chambers 2147 may provideimproved visibility by contrast echocardiography if the chambers 2147are filled with a gas (e.g., CO₂) or other material more visible byechocardiogram.

FIG. 102 illustrates an embodiment of the device 2100 in which theextension member 2110 can include multiple layers 2150 of brim materials2124 and/or support structures 2130. Although, for purposes of clarity,layers 2150 are shown separated in FIG. 102, layers 2150 are preferablystacked in contact with each other without intervening spaces In aparticular example, multiple layers 2150 of woven fabric of polymericsheets with one or more layers of wires 2132 can provide the extensionmember 2110 with a selectable degree of compliance or conformity to thenative tissue. Individual layers 2150 of brim materials 2124 can beformed of the same materials or a combination of materials. Likewise,the support structure 2130 can include layers of wires 2132 having thesame or different arrangements on the layers 2150 of brim materials2124. The wires 2132 can also include a combination of flexible wires(e.g., smaller, less stiff) and stiffer wires. Accordingly the multiplelayers 2150 may include wires 2132 having different wire diameters,geometries, overall size and stiffness. In another embodiment, thelayers 2150 can provide the extension member 2110 with an asymmetricdegree of flexibility. In one example, the lower layers 2151 (e.g.,closer to the ventricle) can be more stiff (e.g., less flexible) thanthe upper layers 2152 that contact atrial chamber tissue. In anotherexample, the extension member 2110 can have an asymmetric degree offlexibility between the side engaging the anterior leaflet (e.g.,greater flexibility) and the sides engaging the posterior leaflet orcommissures (e.g., less flexibility) such that the device 2100 will notsubstantially occlude the LVOT. In a further embodiment, the extensionmember 2110 can also include radiopaque markers 160 (e.g., metallicstrips, rings) placed on or between the layers 2150 to assist invisualization of the device 2100 during and after implantation.

FIG. 103 illustrates an embodiment of the device 2100 having afunnel-shaped extension member 2110 extending from the anchoring member110 in shape that diverges outwardly in an upstream direction. In oneembodiment, the extension member 2110 can include an invertedfunnel-shaped brim 2126 or tube that includes the brim material 2124(e.g., fabric) coupled to the anchoring member 110 and/or integral withthe first sealing member portion 140 a. In another embodiment, theextension member 2110 can include the inverted funnel-shaped brim 2126further supported by support structure comprising struts or wires (notshown).

FIGS. 104A and 104B illustrate an embodiment of the device 2100 in whichthe anchoring member 110 includes a plurality of upstream extendinglobes 2170 and the extension member 2110 positioned beneath (e.g.,downstream) the lobes 2170. In one embodiment, the lobes 2170 can bespaced apart radial struts 2171 (FIG. 104A), or in another embodiment,the lobes 2170 can be spaced apart loops 2172 (FIG. 104B). The lobes2170 can be pre-shaped and connected to or integral with the frame 2109of the anchoring member 110. In one embodiment, the lobes 2170 caninclude metal or other material visible by fluoroscopy or echocardiogramimaging systems (not shown) for visualizing the placement of the device2100.

Referring to FIGS. 104A and 104B together, the lobes 2170 can define theexpected final deployed position of the extension member 2110. As such,the lobes 2170 may limit deflection of the extension member as thedevice 2100 is pulled (e.g., moved downstream) into position.Alternatively or additionally, the lobes 2170 may provide a referencemarker, visible using fluoroscopy, relative to which the degree ofdeflection of the extension member 2110 that may be assessed. Asillustrated in FIGS. 104A and 104B, the angle α is the angle between theradially extended extension member 2110 and the lobes 2170. When theangle α is small, the extension member 2110 extends more longitudinally(e.g., low-profile), and the angle α increases as the extension member2110 extends outwardly. Visualizing the angle α during deployment andimplantation of the device 2100 can allow a practitioner to bettervisualize the position of the device 2100 relative to the native valveanatomy before the anchoring member 110 and valve support withprosthetic valve (not shown) is deployed from the delivery catheter (notshown). For example, in operation, the extension member 2110 can be atleast partially deployed from the delivery catheter (not shown) suchthat the angle α becomes large (e.g., full extension). The device 2100can then be pulled/pushed downstream through the native annulus. As thedevice 2100 is pulled/pushed downstream, the extension member 2110 isdeflected by the native tissue inwardly thereby decreasing the angle α.Visualization of the decreasing angle α can allow the practitioner tosee the extent of the inward deflection as the device 2100 is implantedand, as such, ensure correct positioning of the device at the nativevalve.

FIG. 105 illustrates an embodiment of the device 2100 in which theextension member 2110 includes an expansion ring 2153 separate from theanchoring member 110 in accordance with the present technology. Theexpansion ring 2153 can be flexibly coupled to the anchoring member 110by one or more tethers 2154 or other lines (e.g., sutures, fabricmaterial etc.) spanning a desired distance between the expansion ring2153 and the upstream perimeter 113 of the anchoring member 110. In oneembodiment, the expansion ring 2153 may be formed of a wire frame ormetal mesh. In another embodiment, the expansion ring 2153 may be acylindrical stent connected to the upstream perimeter 113 and/or theframe 2109 of the anchoring member 110 by the tethers 2154. In certainembodiments, a cover or other material can be coupled to the expansionring 2153. In various arrangements, the expansion ring 2153 isstructurally independent (e.g., mechanically isolated) from theanchoring member 110 and can also provide a device delivery positioningaid to ensure the proper position of the anchoring member 110 beforedeployment.

FIGS. 106A and 106B illustrate embodiments of the device 2100 whereinthe extension member 2110 is attached to or otherwise extends from aportion of the valve support 120 (e.g., at a location downstream fromthe upstream portion 112 of the anchoring member 110). In someembodiments this may allow for higher placement of the device 2100within the native annulus (not shown). In the embodiments shown in FIGS.106A and 106B, the extension member 2110 can be connected and/orattached (e.g., via stitching, sutures, rivets, adhesive or othermechanical coupling fasteners or features known in the art) to the valvesupport frame 136 and/or to the second sealing member portion 140 bcoupled to the valve support frame 136 at an upstream end 121 (FIG.106B) or at an intermediate portion 2155. As illustrated in FIGS. 106Aand 106B, and in certain embodiments, the extension member 2110 mayalso, or alternatively, be attached and/or sealed to the anchoringmember 110 at the upstream portion 112 to provide a cover over the gap2108 between the anchor member 110 and the valve support 120 (e.g.,inner skeleton). The extension member 2110 may include a brim material2124 that is impervious to blood or, alternatively, may contain holes toallow fluid to easily pass into the gap 2108. Or the extension member2110 could have holes (not shown) with flap valves (not shown) or othersuitable one-way valves to allow blood or fluid flow only into the gap2108 where the fluid becomes trapped in the space between the anchoringmember 110 and the valve support 120, thus “inflating” the space to addadditional radial rigidity.

FIGS. 107A and 107B illustrate an embodiment of the device 2100 having aseparate extension member 2180 that is a separately deployable componentin accordance with the present technology. The separate extension member2180 can have a brim 2120 and support structure (not shown) similar tothe extension members 2110 described above. In other arrangements (notshown), the separate extension member 2180 can include a supportstructure (e.g., spiral-shaped wire) that is delivered above the annulus(not shown). Additionally, the separate extension member 2180 can alsoinclude one or more docking features 2182 (e.g., hooks, latches, barbs,pins, etc.) configured to engage the anchoring member 110 (e.g., atcorresponding hooks, on frame 2109, etc.). In one embodiment, theseparate extension member 2180 can be delivered by delivery catheter 18to the native valve NV before delivering the anchoring member 110carrying the prosthetic valve (FIG. 107A) to the target site. In someembodiments, the separate extension member 2180 can engage thesupra-annular surface above the annulus A when deployed. Followingdeployment of the separate extension member 2180, the anchoring member110 and valve support 120 can be released from the delivery catheter 18to engage and be retained by the separate extension member 2180 inproper position within the native valve NV (FIG. 107B). In oneembodiment, the separate extension member 2180 can remain implanted atthe native valve NV; however, in other embodiments, the separateextension member 2180 can be removed after the prosthetic valve device2100 is implanted. In other arrangements, the separate extension member2180 and the anchoring member 110 can be delivered as a single componentand the valve support 120 carrying the prosthetic valve can be deliveredseparately.

Referring back to FIGS. 86A-107B, and in the case of mitral valvereplacement, the device 2100 is delivered in a low-profile deliveryconfiguration 2106 such that the extension member 2110 is positioned inthe left atrium and the anchoring member 110 (e.g., fixation portion1710) is positioned at the native valve annulus. The device 2100 ispartially deployed such that the extension member 2110 is release fromthe delivery catheter 18 and allowed to expand radially while theanchoring member 110 is retained in the delivery catheter 18. In many ofthe foregoing embodiments, the extension member 2110 readily foldsrelative to the anchoring member 110. As such, the device 2100 is thendrawn toward the left ventricle which causes the extension member 2110to fold inwardly. The extension member 2110 exerts a force that properlyaligns the anchoring member 110 with the native valve annulus, and therelative position between the extension member 2110 and the anchoringmember 110 can be readily visualized through known imaging techniques toenable the practitioner to accurately position the device 2100 relativeto the native valve structure.

Additionally, as discussed above, the extension member 2110 can havemany different embodiments including a brim 2120 or shoulder thatextends from the anchoring member 110, or an expansion ring 2153 that iscoupled to the anchoring member 110 by at least one line (e.g., tether2154). The brims 2120, shoulders, and/or rings are configured to expandto have a larger diameter than the anchoring member 110 and to flex,flap, and/or fold relative to the anchoring member 110. The extensionmember 2110 is accordingly configured to enhance the positioning,orientation/alignment, and visualization of the device 2100 relative tothe native valve anatomy. In some embodiments, but not necessarily all,the extension member 2110 can provide additional fixation and sealing ofthe device 2100.

Additional Embodiments

Features of the prosthetic heart valve device components described aboveand illustrated in FIGS. 10A-107B can be modified to form additionalembodiments configured in accordance with the present technology. Forexample, the prosthetic heart valve device 1100 illustrated in FIGS.65A-65B without flared anchoring members can include anchoring membersthat are coupled to the valve support or other feature and areconfigured to extend radially outward to engage subannular tissue.Similarly, the prosthetic heart valve devices described above andillustrated in FIGS. 57A-71 can include features such as sealing membersas well as stabilizing features such as arms and tissue engagingelements.

Features of the prosthetic heart valve device components described abovealso can be interchanged to form additional embodiments of the presenttechnology. For example, the anchoring member 1210 of the prostheticheart valve device 1200 illustrated in FIG. 67A can be incorporated intothe prosthetic heart valve device 600 shown in FIGS. 57A-57C.Additionally, many features of the prosthetic heart valve devices 1700,1900, 2000 and 2100 described above with reference to FIGS. 72-107B canbe used with the prosthetic heart valve devices described above withreference to FIGS. 10-71A, and vice versa. In a particular embodiment,extension members 2110 shown in FIGS. 86A-107B can be incorporated, forexample, in the device 100 (FIG. 10A).

The following Examples are illustrative of several embodiments of thepresent technology.

EXAMPLES

1. A prosthetic heart valve device, comprising:

-   -   a valve support having an upstream region and a downstream        region relative to blood flow through a native heart valve of a        human heart, the upstream region being configured to support a        prosthetic valve, the prosthetic valve having a plurality of        leaflets and having an undeformed shape in which the leaflets        coapt sufficiently to prevent backflow through the prosthetic        valve;    -   an anchoring member having a longitudinal dimension and        including a tissue fixation portion, an integration region        coupled to the valve support, and a plurality of lateral        connectors between the tissue fixation portion and the        integration region, wherein the tissue fixation portion is        configured to (a) engage tissue at an implant site located at        and/or downstream of a native annulus of the native heart valve        and (b) be at least partially deformable into a non-circular        shape to adapt to a shape of the tissue at the implant site in a        deployed state, and wherein the lateral connectors have a        lateral section extending in a transverse direction relative to        the longitudinal dimension of the anchoring member and at least        a first transition zone that bends in a direction different than        the transverse direction such that the tissue fixation portion        faces the tissue at the implant site in the deployed state; and    -   wherein the tissue fixation portion of the anchoring member is        mechanically isolated from the upstream region of the valve        support such that the upstream region of the valve support        maintains the undeformed shape if the anchoring member has        deformed in the non-circular shape.

2. A prosthetic heart valve device, comprising:

-   -   an anchoring member having a longitudinal dimension and        including a tissue fixation portion having a first        cross-sectional dimension in a deployed state, an integration        region having a second cross-sectional dimension in the deployed        state less than the first cross-sectional dimension, and a        lateral portion between the tissue fixation portion and the        integration region, wherein—        -   the tissue fixation portion is configured to (a) engage            tissue located at and/or downstream of a native annulus of a            heart valve in a human and (b) be at least partially            deformable into a non-circular shape to adapt to a shape of            the tissue engaged by the tissue fixation portion in a            deployed state, and        -   the lateral portion extends in a direction transverse with            respect to the longitudinal dimension of the anchoring            member and has at least a first transition zone that bends            from the transverse direction to the tissue fixation portion            such that the tissue fixation portion is configured to face            the native annulus in the deployed state; and    -   a valve support having a first region and a second region, the        first region having a cross-sectional shape in the deployed        state configured to support a prosthetic valve such that        prosthetic leaflets of the prosthetic valve contact each other        in the deployed state, and the second region of the valve        support being coupled to the fixation portion of the anchoring        member.

3. The prosthetic heart valve device of any of examples 1-2, wherein theconnectors or lateral portion further include a second transition zonethat bends from the lateral section or lateral portion to theintegration region.

4. The prosthetic heart valve device of any of examples 1-3, wherein theanchoring member has a first end at the tissue fixation portion and asecond end at the integration region, and wherein the first transitionzone bends from the lateral section or lateral portion toward the firstend of the anchoring member and second transition zone bends from thelateral section or lateral portion toward the second end of theanchoring member.

5. The prosthetic heart valve device of any of examples 1-4, wherein theconnectors or lateral portion further include a second transition zone,and wherein the first transition zone bends superiorly and the secondtransition zone bends inferiorly relative to the heart.

6. The prosthetic heart valve device of any of examples 1-5, wherein thefirst transition zone has a concave curvature with respect to thelongitudinal dimension of the anchoring member.

7. The prosthetic heart valve device of example 6, wherein theconnectors further comprise a second transition zone that bends from thelateral section or lateral portion to the integration region, andwherein the second transition zone has a convex curvature with respectto the longitudinal dimension of the anchoring member.

8. The prosthetic heart valve device of any of examples 1-7, wherein thetissue fixation portion extends at least substantially parallel to thelongitudinal dimension of the anchoring member.

9. The prosthetic heart valve device of any of examples 1-8 wherein thelongitudinal dimension is a central longitudinal axis of the anchoringmember, and the tissue fixation portion extends at angle inclinedinwardly toward the central longitudinal axis.

10. The prosthetic heart valve device of any of examples 1-9, whereinthe tissue fixation portion comprises a ring having right cylindricalshape and a plurality of barbs projecting from the ring.

11. The prosthetic heart valve device of any of examples 1-10, whereinthe tissue fixation portion has a height of 10-20 mm and a generallyflat outer surface along the height.

12. The prosthetic heart valve device of any of examples 1-11, whereinthe anchoring member has a first end at the tissue fixation portion anda second end at the integration region, and the second end of theanchoring member is connected to the downstream region of the valvesupport.

13. The prosthetic heart valve device of any of examples 1-11, whereinthe anchoring member has a first end at the tissue fixation portion anda second end at the integration region, and the second end of theanchoring member is connected to the upstream region of the valvesupport.

14. The prosthetic heart valve device of any of examples 1-13, furthercomprising a compartment between the anchoring member and the valvesupport, and a material in the compartment.

15. The prosthetic heart valve device of example 14, wherein thecompartment comprises a fabric container attached to the anchoringmember and/or the valve support, and the material includes at least oneof an anti-clotting agent and/or a healing agent.

16. The prosthetic heart valve device of any of examples 1-15, whereinthe lateral portion comprises an outwardly flared section, and thefixation portion extends at least substantially parallel to thelongitudinal dimension of the anchoring member.

17. The prosthetic heart valve device of any of examples 1-15, whereinthe lateral portion comprises an outwardly extending conical section,and the fixation portion extends at least substantially parallel to thelongitudinal dimension of the anchoring member.

18. A device for implantation at a native mitral valve, the nativemitral valve having a non-circular annulus and leaflets, comprising:

-   -   a valve support having a first region configured to be attached        to a prosthetic valve with a plurality of prosthetic leaflets        and a second region;    -   an anchoring member having a longitudinal dimension and        including a first portion configured to contact tissue at the        non-circular annulus and a second portion having a lateral        portion between the first portion and the valve support;    -   wherein the second portion of the anchoring member is attached        to the second region of the valve support while in a low-profile        configuration in which the anchoring member and the valve        support are configured to pass through vasculature of a human;    -   wherein the lateral portion is transverse to the longitudinal        dimension; and    -   wherein the anchoring member and the valve support are        configured to move from the low-profile configuration to an        expanded configuration in which the first portion of the        anchoring member at least partially adapts to the non-circular        annulus of the native mitral valve and the first region of the        valve support is spaced inwardly from the first portion of the        anchoring member relative to the longitudinal dimension of the        anchoring member such that a shape of the first region of the        valve support is at least partially independent of a shape of        the first portion of the anchoring member.

19. The device of example 18, wherein the first portion of the anchoringmember comprises a tissue fixation portion and the second portion of theanchoring member comprises an integration region.

20. The device of any of examples 18-19, wherein the lateral portioncomprises a plurality of lateral connectors, and individual connectorsinclude a lateral section extending in a transverse direction relativeto the longitudinal dimension of the anchoring member and at least afirst transition zone that bends in a direction different than thetransverse direction such that the first portion or the tissue fixationportion of the anchoring member faces tissue at the implant site in thedeployed state.

21. The device of any of examples 18-20, wherein the connectors orlateral portion further include a second transition zone that bends fromthe lateral section or lateral portion to the valve support.

22. The device of any of examples 18-21, wherein the first portion orthe tissue fixation portion of the anchoring member extends at leastsubstantially parallel to the longitudinal dimension of the anchoringmember.

23. The prosthetic heart valve device of any of examples 18-21 whereinthe longitudinal dimension is a central longitudinal axis of theanchoring member, and the first portion or the tissue fixation portionof the anchoring member extends at angle inclined inwardly toward thecentral longitudinal axis.

24. The prosthetic heart valve device of any of examples 18-23, whereinthe first portion or the tissue fixation portion of the anchoring membercomprises a ring having right cylindrical shape and a plurality of barbsprojecting from the ring.

25. The prosthetic heart valve device of any of examples 18-24, whereinthe anchoring member has a first end at the first portion or the tissuefixation portion and a second end at the second portion or theintegration region, and the second end of the anchoring member isconnected to a downstream region of the valve support.

26. The prosthetic heart valve device of any of examples 18-24, whereinthe anchoring member has a first end at the first portion or the tissuefixation portion and a second end at the second portion or theintegration region, and the second end of the anchoring member isconnected to an upstream region of the valve support.

27. The prosthetic heart valve device of any of examples 18-26, furthercomprising a compartment between the anchoring member and the valvesupport, and a material in the compartment.

28. The prosthetic heart valve device of any of examples 27, wherein thecompartment comprises a fabric container attached to the anchoringmember and/or the valve support, and the material includes at least oneof an anti-clotting agent and/or a healing agent.

29. The prosthetic heart valve device of any of examples 18-28, whereinthe lateral portion comprises an outwardly flared section, and the firstportion or the fixation portion of the anchoring member extends at leastsubstantially parallel to the longitudinal dimension of the anchoringmember.

30. The prosthetic heart valve device of any of examples 18-28, whereinthe lateral portion comprises an outwardly extending conical section,and the first portion or the fixation portion of the anchoring memberextends at least substantially parallel to the longitudinal dimension ofthe anchoring member.

31. A method for operating of a prosthetic heart valve wherein theprosthetic heart valve device including an anchoring member and a valvesupport coupled to the anchoring member in a heart of a human, andwherein the anchoring member has a tissue fixation portion, anintegration region attached to the valve support, and a lateral portionbetween the tissue fixation portion and the integration region, andwherein the method comprises:

-   -   expanding the anchoring member and the valve support such that a        tissue fixation portion has a size and shape that is spaced        apart from the valve support;    -   moving the anchoring member and the valve support such that the        tissue fixation portion deforms to a non-circular shape; and    -   wherein a support region of the valve support is mechanically        isolated from the tissue fixation portion of the anchoring        member such that the support region of the valve support has a        predetermined cross-sectional shape that supports a prosthetic        valve so that prosthetic leaflets of the prosthetic valve        contact each other sufficiently to inhibit backflow through the        prosthetic valve.

32. The method of example 31, wherein the tissue fixation portion of theanchoring member comprises a right cylinder having an outer surface thatextends at least substantially parallel to a longitudinal axis of theanchoring member.

33. The method of any of examples 31-32, wherein the lateral portion hasa lateral section that extends transverse with respect to the valvesupport or the longitudinal axis of the anchoring member and at least afirst transition zone having a first bend from the lateral section tothe tissue fixation portion.

34. The method of example 32, wherein the lateral portion furtherincludes a second transition zone having a second bend from the lateralsection to the integration region.

35. The method of any of examples 33 and 34, wherein the lateral portionprojects outwardly from the integration region and the first bend isangled superiorly from the lateral portion.

36. The method of any of examples 33 and 34, wherein the lateral portionprojects outwardly from the integration region and the first bend isangled inferiorly from the lateral portion.

37. A method for replacement of a native heart valve having an annulusand leaflets coupled to the annulus, the method comprising:

-   -   positioning a prosthetic heart valve device including an        anchoring member and a valve support at a native mitral valve        location in a heart of the patient, wherein the anchoring member        has a first portion and a second portion, and the valve support        has a first region and a second region; and    -   expanding the anchoring member and the valve support while the        second portion of the anchoring member is coupled to the second        region of the valve support such that the first portion of the        anchoring member engages tissue on or downstream of the annulus        and at least partially adapts to a shape of the annulus at the        native mitral valve location;    -   wherein, upon expansion, the first region of the valve support        is spaced inwardly apart from the first portion of the anchoring        member and the first region of the valve support holds a        prosthetic valve having prosthetic leaflets such that the        prosthetic leaflets contact each other sufficiently to inhibit        backflow through the prosthetic valve after the first portion of        the anchoring member has adapted to the shape of the annulus of        the native mitral valve.

38. A prosthetic heart valve device, comprising:

-   -   a valve support having an upstream region and a downstream        region relative to blood flow through a native heart valve of a        human heart, the upstream region being configured to support a        prosthetic valve, the prosthetic valve having a plurality of        leaflets and having an undeformed shape in which the leaflets        coapt sufficiently to prevent backflow through the prosthetic        valve;    -   an anchoring member including an outwardly-facing engagement        surface configured to engage tissue at an implant site on or        below a native annulus of the native heart valve and extend in        an upstream direction at an angle generally parallel to a        longitudinal axis of the anchoring member or tapering inwardly        in the upstream direction, the fixation portion being deformable        into a non-circular shape to adapt to a shape of the tissue at        the implant site in a deployed state; and    -   a connection structure interconnecting the anchoring member to        the valve support;    -   wherein the tissue fixation portion of the anchoring member is        mechanically isolated from the upstream region of the valve        support such that the upstream region of the valve support        maintains the undeformed shape if the anchoring member has        deformed into the non-circular shape.

39. The prosthetic heart valve device of example 38 wherein theconnection structure comprises a plurality of struts each having aninner end connected to the valve support and an outer end connected tothe anchoring member.

40. The prosthetic heart valve device of any of examples 38-39 whereinthe connection structure has a flared portion that flares outwardly inthe upstream direction.

41. The prosthetic heart valve of example 40 wherein the connectionstructure is configured such that the flared portion is disposedentirely downstream of the native annulus when the anchoring member isat the implant site.

42. Prosthetic heart valve device of any of examples 38-41 wherein theconnection structure has an upstream end connected to the anchoringmember, the upstream end being configured for positioning below thenative annulus when the anchoring member is at the implant site.

43. The prosthetic heart valve device of any of examples 38-42 furthercomprising a plurality of barbs on the fixation surface, the barbspointing in the upstream direction and configured to engage the tissueto resist upstream movement of the anchoring member relative to thenative annulus.

44. The prosthetic heart valve device of any of examples 38-43 whereinthe fixation surface is deflectable through a range of angles relativeto the longitudinal axis such that upon engagement with the tissue thefixation surface is movable from an unbiased orientation to an implantedorientation.

45. The prosthetic heart valve device of example 44 wherein the fixationsurface is deflectable through a range of angles relative to theconnecting structure.

46. The prosthetic heart valve device of any of examples 38-45 whereinthe fixation portion has a first flexibility and the connectingstructure has a second flexibility different than the first flexibility.

47. The prosthetic heart valve device of any of examples 38-45 whereinthe fixation portion has a downstream region with a first flexibilityand an upstream region with a second flexibility different than thefirst flexibility.

48. The prosthetic heart valve device of any of examples 38-47 whereinthe fixation portion comprises a skirt covering an inward-facing surfacethereof.

49. The prosthetic heart valve device of example 48 wherein the skirtfurther covers an inward-facing side of the connecting structure.

50. The prosthetic heart valve device of example 48 further comprising atubular valve cover extending around the valve support, the skirt beingattached to the valve cover so as to inhibit blood flow therebetween

51. The prosthetic heart valve device of example 50 wherein the valvecover is disposed on an inward facing surface of the valve support.

52. The prosthetic heart valve device of any of examples 38-51 whereinthe fixation surface is disposed at an angle generally parallel to anoutwardly facing surface of the valve support in an unbiased condition.

53. The prosthetic heart valve device of any of examples 38-52 whereinthe valve support has a downstream end, the anchoring member beingconfigured such that the downstream end is disposed no more than 16 mmdownstream of the native annulus when the engagement surface is at theimplant site.

54. The prosthetic heart valve device of any of examples 38-53 whereinthe fixation surface has a width in a direction parallel to thelongitudinal axis of at least about 10-20 mm.

55. The prosthetic heart valve device of 38-54 wherein the connectingstructure extends a distance parallel to the longitudinal axis of lessthan about 15 mm from the inner end to the outer end.

56. A prosthetic heart valve device, comprising:

a valve support having an upstream region and a downstream regionrelative to blood flow through a native heart valve of a human heart,the upstream region being configured to support a prosthetic valve, theprosthetic valve having a plurality of leaflets and having an undeformedshape in which the leaflets coapt sufficiently to prevent backflowthrough the prosthetic valve; and

an anchoring member including a connection structure and a fixationportion, the connection structure having an inner end connected to thevalve support, an outer end connected to the fixation portion, and anintermediate portion between the inner end and the outer end whichflares outwardly in an upstream direction, the fixation portion havingan outwardly-facing engagement surface configured to engage tissue at animplant site on or below a native annulus of the native heart valve withthe flared portion of the connection structure disposed entirelydownstream of the native annulus, the engagement surface extending in anupstream direction at an angle generally parallel to a longitudinal axisof the anchoring member or tapering inwardly in the upstream direction,the fixation portion being deformable into a non-circular shape to adaptto a shape of the tissue at the implant site in a deployed state;

wherein the fixation portion of the anchoring member is mechanicallyisolated from the upstream region of the valve support such that theupstream region of the valve support maintains the undeformed shape ifthe anchoring member has deformed into the non-circular shape.

57. A prosthetic heart valve device, comprising:

a valve support having an upstream region and a downstream regionrelative to blood flow through a native heart valve of a human heart,the upstream region being configured to support a prosthetic valve, theprosthetic valve having a plurality of leaflets and having an undeformedshape in which the leaflets coapt sufficiently to prevent backflowthrough the prosthetic valve; and

an anchoring member including a connection structure and a fixationportion, the connection structure having an inner end connected to thevalve support and an outer end connected to the fixation portion, thefixation portion having an outwardly-facing engagement surfaceconfigured to engage tissue at an implant site on or below a nativeannulus of the native heart valve, the anchoring member having adownstream region with a first flexibility and an upstream region with asecond flexibility different than the first flexibility, the fixationportion being deformable into a non-circular shape to adapt to a shapeof the tissue at the implant site in a deployed state;

wherein the fixation portion of the anchoring member is mechanicallyisolated from the upstream region of the valve support such that theupstream region of the valve support maintains the undeformed shape ifthe anchoring member has deformed into the non-circular shape.

58. The prosthetic heart valve device of example 57 wherein the upstreamregion is in the fixation portion and the downstream region is in theconnecting structure.

59. The prosthetic heart valve device of example 57 wherein the upstreamregion is in an upstream portion of the fixation portion and thedownstream region is in a downstream portion of the fixation portion.

60. A prosthetic heart valve device comprising:

-   -   an anchoring member having a tubular fixation frame with an        inlet end and an outlet end;    -   a tubular valve support having a first portion coupled to the        anchoring member and a second portion mechanically isolated from        the anchoring member such that the inlet end of the anchoring        member is radially deformable without substantially deforming        the second portion;    -   a valve coupled to the valve support and having at least one        leaflet movable from a closed position in which blood flow is        blocked through the valve support and an open position in which        blood flow is allowed through the valve support in a downstream        direction; and    -   an extension member coupled to the fixation frame and extending        radially outward therefrom, at least a deformable portion of the        extension member being mechanically isolated from the anchoring        member such that the deformable portion of the extension member        is radially deformable without substantially deforming the        anchoring member.

61. The prosthetic heart valve device of example 60 wherein theextension member includes a brim comprised of a sheet of flexiblematerial coupled to the fixation frame and extending radially outwardtherefrom, and a support structure coupled to the brim, wherein thesupport structure is more rigid than the brim.

62. A prosthetic heart valve device comprising:

-   -   an anchoring member having a connection structure and a radially        expandable fixation frame, wherein the connection structure has        a first end coupled to the fixation frame, a second end coupled        to a valve support and a lateral portion that spaces the        fixation frame apart from the valve support;    -   a valve coupled to the valve support and having at least one        leaflet movable from a closed position in which blood flow is        blocked through the interior and an open position in which blood        flow is allowed through an interior in a flow direction from an        inlet end toward an outlet end; and    -   an extension member comprising:        -   a brim comprised of a sheet of flexible material coupled to            the fixation frame and extending radially outward therefrom;            and        -   a support structure coupled to the brim, the support            structure being more rigid than the brim;    -   wherein the extension member is deflectable relative to the        fixation frame about an axis transverse to the flow direction        and the fixation frame is configured to deform at least        partially independently of the valve support.

63. The prosthetic heart valve device of any of examples 61 and 62wherein the support structure is resilient and is more flexible than thefixation frame.

64. The prosthetic heart valve device of any of examples 60-63 whereinthe valve support comprises a generally cylindrical valve frame formedaround a longitudinal axis extending between the inlet and outlet ends.

65. The prosthetic heart valve device of example 64 wherein the valveframe has an upper extremity and a lower extremity, and the anchoringmember is coupled to the lower extremity of the valve frame.

66. The prosthetic heart valve device of example 65 further comprising aplurality of connecting members interconnecting the lower extremity ofthe valve frame and the anchoring member.

67. The prosthetic heart valve device of example 65 wherein an upstreamend of the anchoring member is radially spaced apart from the upperextremity of the valve frame such that the upstream end of the anchoringmember is radially deformable without substantially deforming the upperextremity of the valve frame.

68. The prosthetic heart valve device of any of examples 61-63 whereinthe anchoring member comprises a cover of a flexible material coupled tothe fixation frame and surrounding an interior thereof.

69. The prosthetic heart valve device of example 68 wherein the brim hasan inner edge attached to a circumference of the cover.

70. The prosthetic heart valve device of example 68 wherein the brim andthe cover comprise a continuous sheet of material.

71. The prosthetic heart valve device of any of examples 61 and 62wherein the support structure comprises a plurality of struts.

72. The prosthetic heart valve device of example 71 wherein the strutsare not directly connected to the fixation frame.

73. The prosthetic heart valve device of example 71 wherein the strutsare spaced apart from the fixation frame.

74. The prosthetic heart valve device of example 71 wherein the strutsare coupled directly to the fixation frame.

75. The prosthetic heart valve of any of examples 60-62 wherein theextension member has an unbiased configuration in which it extendsradially outward from the anchoring member and is deflectable to adeflected configuration in which it extends further in an upstreamdirection, the extension member being resiliently biased to return tothe unbiased configuration.

76. The prosthetic heart valve device of example 71 wherein the strutsextend in a radial direction away from the fixation frame.

77. The prosthetic heart valve device of example 71 wherein the strutsform a continuous ring around extension member.

78. The prosthetic heart valve device of example 77 wherein the strutsform a wavy, zig-zag or diamond pattern around the extension member.

79. The prosthetic heart valve device of example 71 wherein the strutsare sewn to the brim.

80. The prosthetic heart valve device of any of examples 60-63 whereinthe extension member comprises a plurality of discreet petals extendingfrom an upstream end of the anchoring member.

81. The prosthetic heart valve device of any of examples 60-63 whereinin a deployed state the fixation frame is configured to engage tissuedownstream of a native annulus of a heart valve and the extension memberis configured to engage tissue upstream of the native annulus.

82. The prosthetic heart valve device of example 81 wherein theextension member is configured align the heart valve device relative tothe native annulus by engaging the tissue upstream of the nativeannulus.

83. The prosthetic heart valve device of any of examples 61-63 whereinthe support structure comprises a resilient metal or polymer mesh.

84. The prosthetic heart valve device of any of examples 61-63 whereinthe support structure is coupled to the fixation frame by a plurality offlexible connecting members, the connecting members being substantiallyless rigid than the fixation frame.

85. The prosthetic heart valve device of any of examples 61-63 whereinthe extension member is coupled to the anchoring member only by thebrim.

86. A prosthetic heart valve device comprising:

-   -   an anchoring member having a tubular fixation frame with an        interior and having an upstream end and a downstream end;    -   a valve coupled to the anchoring member and having at least one        leaflet movable from a closed position in which blood flow is        blocked through the interior and an open position in which blood        flow is allowed through the interior in a flow direction from        the upstream end toward the downstream end; and    -   an extension member comprising:        -   a brim comprised of a sheet of flexible material coupled to            the anchoring member near the upstream end thereof and            extending radially outward therefrom; and        -   a resilient support structure coupled to the brim and being            structurally independent of the fixation frame;    -   wherein the extension member is radially deformable without        substantially deforming the anchoring member.

87. A method of replacing a native heart valve comprising:

-   -   positioning a prosthesis in a first heart chamber upstream of a        native annulus with a delivery device, the prosthesis being in a        collapsed configuration;    -   deploying an extension member of the prosthesis in the first        heart chamber so that the extension member at least partially        expands into an expanded shape while an anchoring member of the        prosthesis remains at least partially collapsed;    -   moving the prosthesis to cause an indicator portion of the        extension member to deflect by engagement with a wall of the        first heart chamber surrounding the native heart valve;    -   visualizing the indicator portion of the extension member to        determine a position of the prosthesis relative to a native        annulus based on the deflection of the indicator portion; and    -   deploying the anchoring member of the prosthesis such that it        expands into engagement with heart tissue downstream of the        native annulus so as to anchor the prosthesis in place.

88. The method of example 87 wherein the indicator portion comprises aradiopaque material, the indicator portion being visualized usingfluoroscopy.

89. The method of example 87 wherein the indicator portion comprises anechogenic material, the indicator portion being visualized usingultrasound.

90. The method of example 87 wherein the indicator portion comprises oneor more metallic members.

91. The method of example 87 wherein the indicator portion deflectsabout an axis generally parallel to a plane containing the nativeannulus.

92. The method of example 87 wherein the indicator portion forms anangle with a plane containing the native annulus, the angle increasingas the indicator portion is deflected.

93. The method of example 92 wherein the indicator portion forms a firstangle with the plane during the visualization step, further comprisingmoving the prosthesis after the visualization step such that theindicator portion forms a second angle with the plane less than thefirst angle before the anchoring member is deployed.

94. A method of replacing a native heart valve comprising:

-   -   positioning a prosthesis in a first heart chamber upstream of a        native annulus with a delivery device, the prosthesis being in a        collapsed configuration;    -   deploying an extension member of the prosthesis in the first        heart chamber so that the extension member at least partially        expands into an expanded shape while an anchoring member of the        prosthesis remains at least partially collapsed;    -   deploying the anchoring member of the prosthesis such that it        expands into engagement with heart tissue downstream of the        native annulus so as to anchor the prosthesis in place; and    -   allowing the extension member to radially deform to a greater        extent than any deformation of the anchoring member.

95. The method of example 94 further comprising expanding a tubularvalve support coupled to the anchoring member, the valve support havinga valve coupled thereto.

96. The method of example 95 wherein the valve support has a lowerextremity coupled to a downstream end of the anchoring member and anupper extremity which is mechanically isolated from an upstream end ofthe anchoring member.

97. The method of example 96 further comprising allowing the anchoringmember to radially deform without substantially deforming the second endof the valve support.

98. The method of example 94 wherein the extension member is coupled tothe anchoring member by a flexible coupling member, the coupling memberbeing substantially less rigid than the anchoring member.

99. The method of example 98 wherein the coupling member is fabric.

100. A prosthetic heart valve device comprising:

-   -   an anchoring member having a radially expandable frame with an        interior and having an upstream end and a downstream end,        wherein the upstream end includes a tissue fixation portion        configured to engage tissue located at and/or downstream of a        native annulus of a heart valve in a subject and configured to        be at least partially deformable to conform to a shape of the        tissue;    -   a valve positioned relative to the anchoring member and having        at least one leaflet movable from a closed position in which        blood flow is blocked through the interior and an open position        in which blood flow is allowed through the interior in a flow        direction from the upstream end toward the downstream end,        wherein the valve is spaced inwardly apart from the tissue        fixation portion of the anchoring member such that the valve        remains competent when the tissue fixation portion is deformed        to conform to the shape of the tissue; and    -   an extension member flexibly coupled to the anchoring member        proximate the upstream end of the expandable frame, wherein the        extension member extends longitudinally along the flow direction        in a low-profile configuration and is biased to project        laterally relative to the flow direction in a deployed        configuration, the extension member being configured to deform        relative to the expandable frame in the deployed configuration.

101. The prosthetic heart valve device of example 100 wherein theextension member comprises a brim projecting from the upstream end ofthe frame.

102. The prosthetic heart valve device of example 100 wherein theextension member comprises a shoulder.

103. The prosthetic heart valve device of example 100 wherein theextension member comprises an expansion ring separate from the anchoringmember, and the device further includes a tether attached to theexpansion ring and the anchoring member.

104. The prosthetic heart valve device of any of examples 101, 102 and103 wherein the brim comprises a cover.

105. The prosthetic heart valve device of example 104 wherein the covercomprises a web material.

106. The prosthetic heart valve device of example 105 wherein the webcomprises a woven, braided and/or grating of flexible material.

107. The prosthetic heart valve device of any of examples 105 and 106wherein the web comprises a shape-memory polymeric material, ashape-memory metal, and/or a fabric.

108. The prosthetic heart valve device of any of examples 101-107wherein the extension member further comprises a support structureattached to the brim.

109. The prosthetic heart valve device of example 108 wherein thesupport structure comprises a stiffening member more rigid than thebrim.

110. The prosthetic heart valve device of example 109 wherein thestiffening member comprises a scaffold formed from a polymeric materialand/or a metal.

111. The prosthetic heart valve device of example 110 wherein thescaffold has a serpentine, zig-zag, diamond pattern, and/or squarepattern.

112. The prosthetic heart valve device of example 111 wherein thescaffold comprises a continuous strut.

113. The prosthetic heart valve device of example 111 wherein thescaffold comprises a plurality of struts that are connected together.

114. The prosthetic heart valve device of any of examples 108-113wherein the support member is spaced apart from the expandable framesuch that support member is only indirectly coupled to the anchoringmember by the brim.

115. The prosthetic heart valve device of examples 108-113 wherein thesupport member is mechanically isolated from the expandable frame.

116. The prosthetic heart valve device of example 115 wherein thesupport member is spaced apart from the frame of the anchoring memberand indirectly coupled to the anchoring member by the brim.

117. The prosthetic heart valve device of any of examples 108-113wherein the support member is directly connected to the expandableframe.

118. A method of replacing a native heart valve comprising:

-   -   positioning a prosthesis in a first heart chamber upstream of a        native annulus with a delivery device, the prosthesis being in a        collapsed configuration;    -   deploying an extension member of the prosthesis in the first        heart chamber so that the extension member at least partially        expands into an expanded shape while a fixation member of the        prosthesis remains at least partially collapsed;    -   moving the prosthesis in a downstream direction such that the        expanded extension member folds at least partially inwardly and        positions the fixation member at a desired location relative to        the native valve annulus; and    -   deploying the fixation member of the prosthesis such that it        expands into engagement with heart tissue downstream of the        native annulus so as to anchor the prosthesis in place.

119. The method of example 118, further comprising visualizing via animaging modality the extension member folding inwardly while moving theprosthesis downstream.

120. The method of any of examples 118 and 119, wherein the extensionmember causes the fixation member to align with the native valveannulus.

121. The method of any of examples 118-120 wherein the extension memberis configured for tissue ingrowth such that the extension memberprovides additional fixation and sealing over time.

Conclusion

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example, whilesteps are presented in a given order, alternative embodiments mayperform steps in a different order. The various embodiments describedherein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

We claim:
 1. A prosthetic heart valve device comprising: an expandableinner frame having a first end region and a second end region, the innerframe comprising a generally tubular body portion having an innersurface and an outer surface; an expandable outer frame having a firstend region and a second end region, the outer frame comprising agenerally tubular body portion having an inner surface and an outersurface, the outer frame comprising a plurality of interconnected closedcells extending circumferentially around the inner frame, wherein theinner surface of the outer frame is spaced from the outer surface of theinner frame; a connection structure extending between and connecting thesecond end region of the outer frame to the second end region of theinner frame, wherein the connection structure is configured to allowmovement of the outer frame relative to the inner frame; a valve memberattached to the inner frame; wherein the first end region of the outerframe is mechanically isolated from the first end region of the innerframe such that the first end region of the inner frame is configured tomaintain a cross-sectional shape while the first end region of the outerframe deforms from a first cross-sectional shape into a secondcross-sectional shape.
 2. The device of claim 1, further comprising aplurality of tissue engagement elements extending outward from the outerframe.
 3. The device of claim 1, further comprising a plurality of barbsextending outward from the outer frame.
 4. The device of claim 1,further comprising a plurality of spikes extending outward from theouter frame.
 5. The device of claim 1, wherein the outer frame is biasedradially outward to apply a compressive force to native tissue at theimplant location.
 6. The device of claim 1, wherein the connectionstructure comprises a plurality of struts each having an inner endconnected to the inner frame and an outer end connected to the outerframe.
 7. The device of claim 6, wherein each strut comprises at leastone bend.
 8. The device of claim 1, wherein the connection structure isattached to the inner frame by a fastener configured to pivot, rotate orflex.
 9. The device of claim 1, wherein the connection structure has aflared portion that flares outwardly from the inner frame.
 10. Thedevice of claim 1, wherein the connection structure has a flared portionthat flares inwardly from the outer frame.
 11. The device of claim 1,wherein the connection structure has a flared portion that flaresoutwardly from the inner frame and a flared portion that flares inwardlyfrom the outer frame.
 12. The device of claim 1, wherein the connectionstructure comprises a flexible web coupling the outer frame to the innerframe.
 13. The device of claim 1, wherein the outer frame is deflectablethrough a range of angles relative to the connection structure.
 14. Thedevice of claim 1, further comprising a sealing member extending aroundthe outer frame.
 15. The device of claim 1, further comprising a sealingmember extending around the inner frame.
 16. The device of claim 1,further comprising a sealing member extending between the inner andouter frames.
 17. The device of claim 1, further comprising a brimextending radially outward from the first end region of the outer frame.18. The device of claim 17, wherein the brim comprises one or morestiffening members.
 19. The device of claim 18, wherein the brimcomprises a fabric coupling the stiffening members to the outer frame.20. The device of claim 1, further comprising a shape memory material.